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Belite Bio, Inc. ADR (BLTE)
NASDAQ:BLTE
US Market

Belite Bio, Inc. ADR (BLTE) AI Stock Analysis

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BLTE

Belite Bio, Inc. ADR

(NASDAQ:BLTE)

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Neutral 62 (OpenAI - 5.2)
Rating:62Neutral
Price Target:
$199.00
▲(8.87% Upside)
BLTE’s score is driven by solid balance-sheet strength but weighed down by pre-revenue financials and rising cash burn. Technicals are bullish with strong trend support, while valuation remains challenging due to ongoing losses. The latest earnings call was a net positive on regulatory/clinical progress and improved liquidity, despite higher expenses and losses.
Positive Factors
Conservative balance sheet / low leverage
Extremely low debt versus sizable equity gives durable financial flexibility for a clinical-stage biotech. This reduces refinancing and solvency risk across multi-year trials, supports strategic collaborations or M&A optionality, and lessens near-term pressure to sell assets or cut programs.
Material cash runway from recent financings
A large, recent cash balance meaningfully extends runway to complete pivotal trials and regulatory filings. This liquidity reduces the immediacy of capital markets dependence, enabling management to focus on evidence generation and commercialization planning without urgent financing-driven program cuts.
Pivotal clinical and regulatory progress
Completion of Phase III enrollments plus regulatory acceptances are durable de-risking events: they strengthen a first-in-class positioning for tinlarebant, support multi-region approval pathways, and materially increase the likelihood of future revenue if pivotal data and filings remain favorable.
Negative Factors
Pre-revenue with widening losses
No product revenue through multiple years means profitability depends entirely on successful trials and launches. Widening losses indicate sustained cash consumption and negative returns on equity, implying persistent dilution risk and reliance on external funding until commercialization.
Accelerating operating cash burn
Rapidly increasing negative operating cash flow shortens the effective runway absent new capital, raising execution risk for multi-year studies. Persistent negative free cash flow heightens vulnerability to market conditions when raising funds and can force program delays or unfavorable financing terms.
Rising expenses and share-based compensation
Sharply higher R&D and G&A, including significant non-cash share-based comp, inflate operating losses and can persist into commercialization, pressuring margins. Rising structural overhead increases the funding requirement and the probability of further equity dilution to sustain growth and operations.

Belite Bio, Inc. ADR (BLTE) vs. SPDR S&P 500 ETF (SPY)

Belite Bio, Inc. ADR Business Overview & Revenue Model

Company DescriptionBelite Bio, Inc, a clinical-stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting atrophic age-related macular degeneration and autosomal recessive stargardt diseases. Its lead product candidate is LBS-008, an oral once-a-day treatment that can reduce and maintain the delivery of vitamin A to the eye to reduce the accumulation of toxic vitamin A by-products in ocular tissue that is in phase 3 clinical trial. The company is also developing LBS-009, an anti-retinol binding protein 4 oral therapy targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, which is in the preclinical development phase. 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.
How the Company Makes MoneyBelite Bio primarily makes money by developing and commercializing pharmaceutical products. The company generates revenue through strategic partnerships and collaborations with other pharmaceutical companies and research institutions, where it may receive upfront payments, milestone payments, and royalties on sales of successfully developed drugs. Additionally, Belite Bio may seek funding through grants and government programs to support its research and development activities, which are critical to advancing its product candidates through clinical trials and towards market approval.

Belite Bio, Inc. ADR Earnings Call Summary

Earnings Call Date:Nov 10, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 27, 2026
Earnings Call Sentiment Neutral
The earnings call reflects significant regulatory progress and strong financial positioning through successful funding. However, these positives are counterbalanced by increased losses and rising expenses, primarily due to share-based compensation and trial costs.
Q3-2025 Updates
Positive Updates
Regulatory Progress in Key Markets
Positive feedback from major regulatory agencies, including China's NMPA and the U.K.'s MHRA, agreeing to accept priority and conditional marketing authorization applications based on interim analysis results from the Phase III DRAGON trial.
Successful Funding Initiatives
Completed a $50 million registered direct offering and a $125 million private placement, with the potential for an additional $165 million upon full warrant exercise, resulting in a strong cash position of $275.6 million.
Advancement in Clinical Trials
Completed enrollment of the Phase III PHOENIX trial for GA with 530 subjects and the Phase III DRAGON trial for Stargardt's disease, with ongoing enrollment in the DRAGON II trial.
Negative Updates
Increased Net Loss
Reported a net loss of $21.7 million compared to $8.7 million for the same period last year, primarily attributed to increased R&D and G&A expenses, including share-based compensation.
Higher R&D and G&A Expenses
R&D expenses increased to $10.3 million from $6.8 million last year due to trial costs, and G&A expenses rose to $12.7 million from $2.9 million, driven by share-based compensation.
Company Guidance
During the Belite Bio Third Quarter 2025 Earnings Call, the company shared significant updates and guidance for their clinical and financial progress. Key clinical developments included the completion of enrollment for the Phase III PHOENIX trial with 530 subjects for GA, and the completion of the Phase III DRAGON trial for Stargardt's disease, with final top-line data expected by the end of November 2025. The DRAGON II trial is ongoing with 35 out of the targeted 60 subjects enrolled. Regulatory advancements were highlighted, including acceptance for NDA priority review by China's NMPA and conditional marketing authorization by the U.K.'s MHRA based on interim analysis results from the DRAGON trial. Financially, the company reported Q3 2025 R&D expenses of $10.3 million, up from $6.8 million in 2024, and G&A expenses of $12.7 million, up from $2.9 million. The net loss for the quarter was $21.7 million, with a significant portion attributed to $12.9 million in non-cash share-based compensation expenses. The company further strengthened its financial position by completing a $50 million registered direct offering and a $125 million private placement, with potential additional proceeds of $165 million from warrant exercises, resulting in $275.6 million in cash and liquidity at the end of the quarter. These funds are expected to support ongoing clinical trials and commercialization efforts.

Belite Bio, Inc. ADR Financial Statement Overview

Summary
Strong balance-sheet conservatism (minimal debt vs. sizable equity) supports flexibility, but the company is still pre-revenue with widening multi-year losses and accelerating cash burn, raising ongoing funding and execution risk.
Income Statement
18
Very Negative
BLTE remains a pre-revenue biotech with $0 revenue across 2020–2024, so profitability is entirely driven by operating spend rather than commercialization. Losses have widened meaningfully over time (net loss roughly -$5.8M in 2020 to -$36.1M in 2024), indicating rising R&D and operating expenses. A modest positive is that 2024 net loss was only slightly worse than 2023, but the overall trajectory is still sharply negative with no revenue base yet.
Balance Sheet
74
Positive
The balance sheet looks conservative on leverage: total debt is minimal in 2024 (~$0.5M) against a large equity base (~$145.8M), implying very low financial risk from borrowing. Assets and equity expanded substantially from 2022 to 2024, consistent with successful capital raising. The key weakness is that returns on equity are negative due to ongoing losses, and the business will likely continue consuming equity capital until revenue arrives.
Cash Flow
28
Negative
Cash generation is weak, with operating cash flow and free cash flow consistently negative and the cash burn accelerating (operating cash flow about -$4.4M in 2020 to -$29.2M in 2024). Free cash flow tracks closely to net loss, suggesting limited non-cash offsets and a business model still in heavy investment mode. While negative cash flow is common for development-stage biotech, the increasing burn rate raises execution and funding-timing risk.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit0.000.000.00-198.00K-30.00K0.00
EBITDA-49.04M-35.67M-31.20M-12.43M-9.64M-5.73M
Net Income-49.38M-36.14M-31.63M-12.65M-9.67M-5.75M
Balance Sheet
Total Assets156.41M152.13M94.64M44.27M18.35M25.74M
Cash, Cash Equivalents and Short-Term Investments0.00145.15M88.16M42.09M17.34M25.62M
Total Debt0.00537.00K886.00K866.00K31.81M31.81M
Total Liabilities6.52M6.31M4.21M2.77M33.44M32.78M
Stockholders Equity149.88M145.82M90.43M41.50M-15.09M-7.04M
Cash Flow
Free Cash Flow0.00-29.39M-29.90M-11.85M-7.55M-4.46M
Operating Cash Flow0.00-29.23M-29.84M-11.46M-7.47M-4.44M
Investing Cash Flow0.00-110.57M-63.00K-394.00K-56.00K-20.00K
Financing Cash Flow0.0083.59M75.96M36.96M-583.00K28.06M

Belite Bio, Inc. ADR Technical Analysis

Technical Analysis Sentiment
Positive
Last Price182.79
Price Trends
50DMA
156.46
Positive
100DMA
123.64
Positive
200DMA
93.41
Positive
Market Momentum
MACD
7.30
Negative
RSI
64.29
Neutral
STOCH
58.99
Neutral
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 182.79 is above the 20-day moving average (MA) of 164.56, above the 50-day MA of 156.46, and above the 200-day MA of 93.41, indicating a bullish trend. The MACD of 7.30 indicates Negative momentum. The RSI at 64.29 is Neutral, neither overbought nor oversold. The STOCH value of 58.99 is Neutral, 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 115 risk factors in its most recent earnings report. Belite Bio, Inc. ADR reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Belite Bio, Inc. ADR Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
81
Outperform
$2.15B11.4725.93%21.13%50.86%
70
Outperform
$3.30B97.067.39%55.68%
62
Neutral
$6.38B-92.89-32.30%-73.27%
54
Neutral
$3.32B-6.88-44.44%-5.30%
53
Neutral
$2.73B-5.58-47.19%-84.07%-157.71%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$3.36B-12.93-60.45%117.83%-18.91%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BLTE
Belite Bio, Inc. ADR
178.33
119.29
202.05%
DNLI
Denali Therapeutics
20.02
-2.51
-11.14%
KNSA
Kiniksa Pharmaceuticals
42.58
22.29
109.86%
BEAM
Beam Therapeutics
24.73
-2.92
-10.56%
HRMY
Harmony Biosciences Holdings
36.41
-2.37
-6.11%
CNTA
Centessa Pharmaceuticals
23.54
5.70
31.95%

Belite Bio, Inc. ADR Corporate Events

Belite Bio Completes Global Enrollment in DRAGON II Tinlarebant Trial for Stargardt Disease
Jan 27, 2026

On January 27, 2026, Belite Bio announced it has completed enrollment of 60 adolescent patients, including 15 in Japan, in its global Phase 2/3 DRAGON II trial of tinlarebant for Stargardt disease type 1, a 24‑month randomized, double‑masked, placebo‑controlled study spanning Japan, the United States and the United Kingdom. The milestone, achieved after tinlarebant previously met the primary endpoint in the pivotal Phase 3 DRAGON trial with a 36% reduction in lesion growth, advances Belite’s registration strategy in both the U.S. and Japan and keeps the company on track to file a U.S. New Drug Application in the first half of 2026, reinforcing its position as a front-runner in developing the first disease-modifying treatment for STGD1 and potentially strengthening its standing in the broader retinal disease market.

The most recent analyst rating on (BLTE) stock is a Buy with a $195.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Belite Bio Prices $350 Million ADS Offering to Boost Drug Development
Dec 2, 2025

On December 1, 2025, Belite Bio announced the pricing of a $350 million underwritten public offering of American Depositary Shares, each representing one ordinary share, at $154.00 per ADS. The offering, expected to close on December 3, 2025, aims to support commercialization preparation, pipeline development, and general corporate purposes. This move is significant for Belite Bio as it seeks to strengthen its market position and advance its drug development efforts, particularly for its lead candidate, Tinlarebant.

The most recent analyst rating on (BLTE) stock is a Buy with a $194.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Belite Bio Reports Increased Cash Reserves Amid Rising R&D Costs
Dec 1, 2025

Belite Bio, Inc. released its unaudited interim condensed consolidated financial statements for the nine months ending September 30, 2025. The company reported a significant increase in cash and cash equivalents, rising from $31.7 million at the end of 2024 to $157 million by September 2025. Despite this, the company experienced a net loss of $52.3 million during the same period, primarily due to increased research and development expenses. The financial results reflect Belite Bio’s ongoing investment in its pipeline, which could impact its market positioning and stakeholder confidence as it continues to focus on long-term growth and innovation.

The most recent analyst rating on (BLTE) stock is a Buy with a $185.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Belite Bio Announces Public Offering of ADSs to Fund Expansion
Dec 1, 2025

On December 1, 2025, Belite Bio, Inc announced the commencement of an underwritten public offering of American Depositary Shares, each representing one ordinary share. The proceeds from this offering are intended for commercialization preparation, pipeline development, and general corporate purposes. The offering is subject to market conditions, and its completion is not guaranteed, highlighting potential impacts on the company’s operational expansion and market positioning.

The most recent analyst rating on (BLTE) stock is a Buy with a $185.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Belite Bio Reports Breakthrough Phase 3 Results for Stargardt Disease Treatment
Dec 1, 2025

On December 1, 2025, Belite Bio announced positive results from its Phase 3 DRAGON trial for Tinlarebant, a treatment for Stargardt disease. The trial demonstrated a significant reduction in retinal lesion growth, marking a potential breakthrough for a condition with no current approved treatments. The successful trial positions Belite Bio to file for regulatory approval in 2026, potentially offering new hope to over 50,000 affected individuals in the U.S. The findings underscore the company’s commitment to addressing unmet medical needs and could significantly impact the treatment landscape for retinal disorders.

The most recent analyst rating on (BLTE) stock is a Buy with a $154.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Belite Bio Announces Q3 2025 Results and Key Trial Progress
Nov 10, 2025

On November 10, 2025, Belite Bio reported its financial results for the third quarter of 2025 and provided a corporate update. The company completed enrollment in its pivotal phase 3 PHOENIX trial for geographic atrophy and the DRAGON trial for Stargardt disease, with final topline data expected in Q4 2025. Regulatory agencies in China and the UK have accepted applications for Tinlarebant based on interim analysis results. Financially, Belite Bio completed a $15 million registered direct offering and a $125 million private placement, strengthening its position to advance Tinlarebant towards regulatory milestones.

The most recent analyst rating on (BLTE) stock is a Buy with a $132.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

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.Date of analysis: Dec 30, 2025