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Belite Bio, Inc
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NASDAQ: BLTE Healthcare Pharma 🔎 Screen
$5.2B
Market Cap
—
P/E
—
PEG
-60.2%
ROCE
-16.9%
ROE
0.00
D/E
—
OPM
-21.2%
% from 52W High
89
α RS
🔍 BLTE is showing a sector-leadership setup because Sector RRG has Health Care in the Leading quadrant with the trail still strengthening, it matches 2 of 39 tracked screener presets, and RS Rating is 89. The main caution: the Fortress Balance preset's Backtest win rate is only 38.6%. Net: Mixed signal stack, not a recommendation. ? RRG Conviction RS Rating Backtest
Sources
Health Care in Leading quadrant · Conviction 2/39 · RS Rating 89 · Backtest win rate 38.6%
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Ratio Health
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About

Belite Bio, Inc, a clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics with unmet medical needs in the United States. Its lead product candidate is Tinlarebant (LBS-008), an orally administered, which is in phase 3 clinical trial as an early intervention for maintaining the health and integrity of retinal tissues in stargardt disease type 1 and geographic atrophy patients. The company also develops LBS-009, an retinol binding protein 4 oral therapy, which is in preclinical development targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, as well as gout. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc operates as a subsidiary of Lin Bioscience International Ltd.

Key Ratios Snapshot
📈 Growth Pattern
📊 Quick Scorecard
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⭐ Superinvestors Holding BLTE
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Manager Shares Value % of Fund Period
Stan Druckenmiller Duquesne Family Office 106.1K $16.9M 0.50% Mar 2026
Jim Simons Renaissance Technologies LLC 52.0K $8.3M 0.01% Mar 2026

SEC Form 13F data. 45-day lag from quarter end.

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📊 MIXED Belite Bio progressing NDA submission for Stargardt disease; strong cash position of $799M.
Revenue & Profitability
Belite Bio reported no revenue in Q1 2026. GAAP net loss was $26.9 million compared to $14.3 million in Q1 2025. GAAP R&D expenses were $15.7 million (non-GAAP $13.8 million) and GAAP SG&A expenses were $17 million (non-GAAP $5.7 million). Non-GAAP net loss was $13.7 million. Cash and U.S. Treasury bills totaled $799 million at quarter end.
Outlook
Management views the unmet need in Stargardt disease as significant, with retinal specialists enthusiastic about a first-ever treatment. The company expects FDA review of the NDA within six months and potential Japan approval within three months of FDA approval. Payers have been supportive of pricing in the range of $350,000 to $500,000 per year. The GA interim analysis is anticipated around year-end 2026.
Growth Drivers
Key growth drivers include expected FDA approval and U.S. commercial launch of Tinlarebant for Stargardt disease, the ongoing DRAGON II trial for Japan registration, and the potential geographic atrophy indication (interim analysis expected year-end 2026). The company is building a 30-40 person commercial team targeting retina specialists and patient advocacy groups to drive awareness and uptake.
Balance Sheet & CapEx
Not explicitly discussed as capital expenditure; however, management noted significant investment in R&D (including DRAGON II trial and manufacturing) and SG&A (team expansion and commercial preparation). The company budgets approximately $150 million for the pipeline over three years and estimates up to $300 million for the Stargardt launch, with $450 million total needed against $800 million cash. Supply chain and manufacturing are being readied for a rapid launch upon approval.
Margins
Not discussed in this earnings call as the company is pre-revenue. Management noted that R&D and SG&A expenses are increasing as they build the commercial team and conduct trials. Cash position of $799 million is expected to cover launch and pipeline investments without margin guidance.
Key Risks
Risks flagged include reliance on FDA approval and potential need for DRAGON II data for U.S. filing (though management believes DRAGON I data may suffice). The GA interim analysis is data-dependent and could impact strategy. Commercial execution and expense increases are also risks. The company highlighted that forward-looking statements involve risks and uncertainties.
Generated by AI · Q1 2026 results · Not investment advice
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✓ 📞 Earnings Call Transcripts (5 quarters) submit a missing quarter
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📞 Earnings Call Transcripts (5)
Q1 2026 Q1 2026 2026-05-20
NDA rolling submission for Stargardt disease is underway, with commercial launch preparations and strong cash reserves supporting expansion. R&D and SG&A expenses rose sharply year-over-year, driven by clinical and pre-commercial activities. FDA approval remains the top priority.
Q4 2025 Q4 2025 2026-03-02
Key 2025 milestones included positive phase III results for Stargardt disease, strong fundraising, and a robust cash position. NDA submission is planned for Q2 2026, with commercialization targeted for Q1 2027 and significant investments in launch preparation.
Q3 2025 Q3 2025 2025-11-10
Phase 3 trials for GA and Stargardt disease reached key milestones, with top-line DRAGON data due soon. Regulatory agencies in China and the U.K. will accept applications based on interim results. Strong cash position and recent capital raises support commercialization plans.
Q2 2025 Q2 2025 2025-08-11
Tinlarebant advanced in global phase three trials for Stargardt’s disease and geographic atrophy, with strong regulatory momentum and a four-year cash runway. Q2 net loss widened due to higher R&D and G&A expenses, mainly from share-based compensation.
Q1 2025 Q1 2025 2025-05-14
Tinlarebant clinical trials advanced with strong interim results and regulatory support, while Q1 2025 saw increased R&D and G&A expenses mainly from non-cash share-based compensation. Cash reserves of $157.4M provide a four-year runway to complete all trials.
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Financial Model
Projections are built from each company's audited annual financials (Income Statement, Balance Sheet, Cash Flow) over the last 5 fiscal years. Forward assumptions — revenue growth %, EBITDA margin, D&A (USD millions), interest expense, tax rate, and capex — are AI-generated using historical context and refreshed twice a year: after the December results season and after the September/Q4 results season.

DCF Valuation
Fair Value = Σ(FCFt / (1+WACC)t) + Terminal Value. Terminal Value uses the Gordon Growth Model: FCF5 × (1+g) / (WACC−g). Default WACC: 10% (US risk-free ~4.5%, equity risk premium ~5.5%). Default terminal growth: 3% (long-run US nominal GDP proxy).

CAGR Tracker
Expected 5-year CAGR = (DCF Fair Value / Current Price)1/5 − 1. Assumes fair value is reached in exactly 5 years — a mechanical estimate only.

Data Sources & Limitations
Financial statements sourced from public filings. Prices updated daily. Forward assumptions are AI-generated. All monetary values in USD millions. Non-US ADR companies may have currency conversion inaccuracies. Models are point-in-time and do not update intra-quarter or account for M&A, macro shocks, or extraordinary items.

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Investment Risk:
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Information Sources:
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