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Belite Bio, Inc. ADR
(NASDAQ:BLTE)
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Rating:57Neutral
Price Target:
$169.00
▲(10.20% Upside)
Action:Reiterated
Date:06/03/26
BLTE’s score is held back primarily by weak current financial performance (no revenue, widening losses, and ongoing cash burn), with additional pressure from bearish technicals. These are partly offset by a very strong balance sheet and a constructive earnings update highlighting NDA progress, clinical execution milestones, and substantial cash runway.
Positive Factors
Strong Balance Sheet / Cash Runway
A nearly $800M cash base and minimal debt materially reduces near-term financing risk and funds late-stage filings, commercial build and manufacturing. This durable liquidity supports execution across regulatory review, commercial launch prep and trial completion over the next 2–6 months.
Negative Factors
Pre‑revenue with Widening Losses
No product revenue and expanding net losses mean the company remains dependent on cash reserves and capital markets. Even with robust cash, persistent negative returns on equity indicate capital is funding development not generating profit, limiting financial resilience if timelines slip.
Read all positive and negative factors
Positive Factors
Negative Factors
Strong Balance Sheet / Cash Runway
A nearly $800M cash base and minimal debt materially reduces near-term financing risk and funds late-stage filings, commercial build and manufacturing. This durable liquidity supports execution across regulatory review, commercial launch prep and trial completion over the next 2–6 months.
Read all positive factors
Belite Bio, Inc. ADR (BLTE) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$7.17B
Dividend YieldN/A
Average Volume (3M)64.23K
Price to Earnings (P/E)―
Beta (1Y)0.74
Revenue GrowthN/A
EPS Growth-76.46%
CountryUS
Employees41
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.55
Shares Outstanding39,965,313
10 Day Avg. Volume75,810
30 Day Avg. Volume64,229
Financial Highlights & Ratios
PEG Ratio-0.72
Price to Book (P/B)6.96
Price to Sales (P/S)0.00
P/FCF Ratio-144.35
Enterprise Value/Market Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price Target
$221.00Price Target Upside44.11% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering6
EPS Forecast (FY)-3.01
Revenue Forecast (FY)N/A
Belite Bio, Inc. ADR Business Overview & Revenue Model
Company Description
Belite Bio, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and advancement of novel therapies. The firm's primary therapeutic areas include atrophic age-related macular degeneration and autosomal recessive Stargardt di...
How the Company Makes Money
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Belite Bio, Inc. ADR Earnings Call Summary
Earnings Call Date:Aug 13, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 17, 2026
Earnings Call Sentiment Positive
Overall the call conveyed substantial positive progress: NDA acceptance with priority review and a clear PDUFA date, supportive Phase 3 QAF data, strong cash balance ($780M), a pediatric program, and high patient compliance. Counterbalancing these positives are materially higher R&D and SG&A expenses, a widening net loss, a confidential one‑time royalty payment, limited disclosure on manufacturing inspection status, and a delayed GA interim readout. The positives (regulatory momentum, strong efficacy signal, and financial runway) outweigh the operational and expense-related concerns.Positive Updates
NDA Accepted with Priority Review and PDUFA Date
FDA accepted the tinlarebant NDA with priority review and set a PDUFA date of 2027-02-12, signaling regulatory momentum toward potential US approval.
Negative Updates
Marked Increase in R&D Expenses
R&D expenses for Q2 FY26 were $18.2M vs $11.0M in Q2 FY25 (+65%), and non-GAAP R&D (ex share‑based comp) were $17.2M vs $8.6M (+100%); increase driven in part by a royalty payment tied to Phase 3 completion.
Read all updates
Q2-2026 Updates
Positive
Negative
NDA Accepted with Priority Review and PDUFA Date
FDA accepted the tinlarebant NDA with priority review and set a PDUFA date of 2027-02-12, signaling regulatory momentum toward potential US approval.
Read all positive updates
Company Guidance
On the Q2 2026 call management confirmed FDA acceptance of the tinlarebant NDA with priority review and a PDUFA date of February 12, 2027, highlighted Phase 3 Dragon data presented at four conferences in four countries (ASRS data showing ~2% QAF decrease at month 25 with tinlarebant vs ~20% QAF increase on placebo), said Dragon 2 is primarily a Japan/PMDA study, and outlined financials: Q2 R&D $18.2M (non‑GAAP ex‑SBC $17.2M) vs $11.0M/$8.6M year‑ago, SG&A $16.7M (non‑GAAP $10.9M) vs $6.5M/$1.3M, GAAP net loss $28.4M (non‑GAAP net loss $21.6M) vs $16.3M/$8.7M, and $780M in cash/cash equivalents/T‑bills providing a runway to commercialize after potential approval; other guidance included a pediatric PIP study in London for ages 3–11, >90% dosing compliance at 24 months, expectation of a priority review voucher if approved, a GA interim readout likely in Q1 2027 (after the PDUFA period), a planned Japan submission ~3 months after U.S. approval, and a European filing to follow post‑U.S. approval.Belite Bio, Inc. ADR Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
86
Very Positive
Cash Flow
32
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Mar 2023 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | 0.00 | -198.00K | -30.00K |
| EBITDA | -95.59M | -77.15M | -35.67M | -31.20M | -12.43M | -9.64M |
| Net Income | -90.27M | -77.61M | -36.14M | -31.63M | -12.65M | -9.67M |
Balance Sheet | ||||||
| Total Assets | 811.27M | 780.56M | 152.13M | 94.64M | 44.27M | 18.35M |
| Cash, Cash Equivalents and Short-Term Investments | 0.00 | 492.42M | 145.15M | 88.16M | 42.09M | 17.34M |
| Total Debt | 0.00 | 429.00K | 537.00K | 886.00K | 866.00K | 31.81M |
| Total Liabilities | 15.48M | 10.07M | 6.31M | 4.21M | 2.77M | 33.44M |
| Stockholders Equity | 795.79M | 770.49M | 145.82M | 90.43M | 41.50M | -15.09M |
Cash Flow | ||||||
| Free Cash Flow | -10.56K | -37.17M | -29.39M | -29.90M | -11.85M | -7.55M |
| Operating Cash Flow | -10.38K | -36.99M | -29.23M | -29.84M | -11.46M | -7.47M |
| Investing Cash Flow | -303.73K | -305.11M | -110.57M | -63.00K | -394.00K | -56.00K |
| Financing Cash Flow | 510.12K | 663.23M | 83.59M | 75.96M | 36.96M | -583.00K |
Belite Bio, Inc. ADR Risk Analysis
Belite Bio, Inc. ADR disclosed 111 risk factors in its most recent earnings report. Belite Bio, Inc. ADR reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 2 New Risks
1.
We no longer qualify as an "emerging growth company" and, as a result, we are no longer able to avail ourselves of certain reduced reporting requirements applicable to emerging growth companies. Q4, 2025
2.
We will rely on third parties to manufacture clinical and commercial supplies of tinlarebant and other product candidates and future products. Q4, 2025
Belite Bio, Inc. ADR Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
59 Neutral | $6.32B | -13.55 | -43.98% | ― | -100.00% | -33.88% | |
58 Neutral | $5.86B | -136.51 | -26.79% | ― | 77.12% | 64.40% | |
57 Neutral | $7.17B | -65.21 | -18.14% | ― | ― | -76.46% | |
56 Neutral | $8.10B | -37.31 | -80.48% | ― | 53.51% | -3.31% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $6.06B | -146.88 | 21.72% | ― | -42.84% | -106.21% | |
47 Neutral | $6.43B | -6.79 | -410.20% | ― | 44.02% | -1101.02% |
* Healthcare Sector Average
BLTE
Belite Bio, Inc. ADR
166.28
97.30
141.06%
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Belite Bio, Inc. ADR Corporate Events
Belite Bio Kicks Off Tinlarebant NDA and Ramps Up Commercial Build-Out on Strong Cash Base
May 20, 2026
On May 20, 2026, Belite Bio reported unaudited results for the quarter ended March 31, 2026, alongside a broad corporate update that underscores its transition toward commercialization. The company has begun a rolling U.S. NDA submission for tinla...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.