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Belite Bio, Inc. ADR
(NASDAQ:BLTE)
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Rating:62Neutral
Price Target:
$204.00
▲(30.19% Upside)
Action:Reiterated
Date:08/19/26
BLTE scores moderately due to a very strong, low-debt balance sheet and a favorable regulatory update on the latest call (priority review with a defined PDUFA date, plus supportive Phase 3 data), supported by moderately positive technical trends. These positives are tempered by the company’s pre-revenue status, widening losses and ongoing cash burn, and a valuation profile that lacks traditional support (negative P/E and no dividend).
Positive Factors
Dual-region regulatory progress
Tinlarebant has advanced into formal regulatory review in both Japan and the United States, including expedited pathways. This materially improves development visibility, supports potential earlier access in two markets, and strengthens Belite Bio’s position as a first mover in Stargardt disease.
Negative Factors
Pre-revenue business model
Belite Bio has no approved-product revenue to offset development and commercial preparation costs, so its economic model remains dependent on successful regulatory approval and future launch execution. Until monetization begins, financial performance will remain exposed to trial, approval, and market-entry outcomes.
Read all positive and negative factors
Positive Factors
Negative Factors
Dual-region regulatory progress
Tinlarebant has advanced into formal regulatory review in both Japan and the United States, including expedited pathways. This materially improves development visibility, supports potential earlier access in two markets, and strengthens Belite Bio’s position as a first mover in Stargardt disease.
Read all positive factors
Belite Bio, Inc. ADR (BLTE) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$7.80B
Dividend YieldN/A
Average Volume (3M)189.10K
Price to Earnings (P/E)―
Beta (1Y)0.76
Revenue GrowthN/A
EPS Growth-76.46%
CountryUS
Employees41
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.76
Shares Outstanding40,272,144
10 Day Avg. Volume215,753
30 Day Avg. Volume189,102
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
$236.86Price Target Upside51.16% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
EPS Forecast (FY)-3.23
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
Belite Bio is a pre-commercial, clinical-stage biotechnology company. Public, product-based revenue streams from approved products are not available (null). The company historically funds operations primarily through financing activities typical f...
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 | -114.22M | -77.15M | -35.67M | -31.20M | -12.43M | -9.64M |
| Net Income | -102.36M | -77.61M | -36.14M | -31.63M | -12.65M | -9.67M |
Balance Sheet | ||||||
| Total Assets | 791.58M | 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 | 14.95M | 10.07M | 6.31M | 4.21M | 2.77M | 33.44M |
| Stockholders Equity | 776.64M | 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 Technical Analysis
Positive
156.69
Price Trends
159.10
Positive
154.25
Positive
158.23
Positive
Market Momentum
5.17
Negative
71.77
Negative
94.79
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BLTE, the sentiment is Positive. The current price of 156.69 is below the 20-day moving average (MA) of 165.98, below the 50-day MA of 159.10, and below the 200-day MA of 158.23, indicating a bullish trend. The MACD of 5.17 indicates Negative momentum. The RSI at 71.77 is Negative, neither overbought nor oversold. The STOCH value of 94.79 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for BLTE.
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 |
|---|---|---|---|---|---|---|---|
62 Neutral | $7.80B | -69.87 | -15.65% | ― | ― | -76.46% | |
58 Neutral | $6.15B | -146.82 | -55.79% | ― | 77.12% | 64.40% | |
58 Neutral | $5.79B | -12.56 | -43.98% | ― | -100.00% | -33.88% | |
56 Neutral | $7.07B | -32.73 | -80.48% | ― | 53.51% | -3.31% | |
52 Neutral | $5.78B | -140.43 | 21.72% | ― | -42.84% | -106.21% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
47 Neutral | $6.55B | -6.84 | -410.20% | ― | 44.02% | -1101.02% |
* Healthcare Sector Average
BLTE
Belite Bio, Inc. ADR
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191.01%
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Belite Bio, Inc. ADR Corporate Events
Belite Bio Files Sakigake-Backed Tinlarebant NDA in Japan for Stargardt Disease
Sep 8, 2026
On September 8, 2026, Belite Bio announced it has submitted a New Drug Application to Japan’s Ministry of Health, Labour and Welfare for tinlarebant to treat Stargardt disease type 1, a rare inherited retinal disorder that currently has no a...
Belite Bio Gains FDA Priority Review for Tinlarebant as Losses Widen on Commercial Build-Out
Aug 13, 2026
On August 12, 2026, Belite Bio reported unaudited second-quarter 2026 results and a corporate update, highlighted by the U.S. Food and Drug Administration’s acceptance of its New Drug Application for tinlarebant in Stargardt disease type 1 w...
Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease
Aug 11, 2026
On August 11, 2026, Belite Bio announced that the U.S. Food and Drug Administration accepted and granted Priority Review to its New Drug Application for tinlarebant to treat Stargardt Disease Type 1, setting a Prescription Drug User Fee Act target...
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.