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

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BLTE

Belite Bio, Inc. ADR

(NASDAQ:BLTE)

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Neutral 43 (OpenAI - 4o)
Rating:43Neutral
Price Target:
Belite Bio faces significant financial challenges with no revenue and increasing losses, impacting its overall score. Technical indicators show neutral momentum, and valuation is unattractive with negative earnings. However, the earnings call highlights clinical advancements and financial stability, providing a positive outlook in the long term despite current financial difficulties.
Positive Factors
Clinical Advancements
The regulatory designations for Tinlarebant indicate strong potential for approval and market entry, enhancing Belite Bio's competitive position in treating Stargardt disease and geographic atrophy.
Financial Stability
The company's substantial cash reserves and investments provide a solid financial runway, supporting ongoing R&D activities and mitigating short-term financial risks.
Strong Trial Enrollment
Successful enrollment in clinical trials demonstrates strong interest and potential for successful study outcomes, which are critical for regulatory approval and future revenue generation.
Negative Factors
Increasing Net Loss
Rising net losses highlight ongoing financial challenges, which could strain resources and delay the company's path to profitability if not managed effectively.
Adverse Events in Trials
Adverse events in clinical trials can impact patient recruitment and retention, potentially delaying trial completion and affecting the drug's marketability.
High Dropout Rate
A high dropout rate in trials can compromise data integrity and delay results, affecting the timeline for regulatory submissions and market entry.

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
Belite Bio, Inc. faces significant financial challenges, with persistent lack of revenue and increasing losses impacting its income statement. Although there have been improvements in equity levels, the company's balance sheet reflects past high leverage and current reliance on financing activities. The cash flow statement highlights ongoing operational cash deficits, stressing the importance of achieving revenue growth and effective cash management.
Income Statement
10
Very Negative
The company has consistently reported zero revenue, indicating no commercial products or services generating income. Net income is negative, worsening from -$12.48 million in 2022 to -$31.63 million in 2023, reflecting increasing losses. EBIT and EBITDA margins are negative, emphasizing operational challenges and a lack of profitability.
Balance Sheet
30
Negative
The company has a positive stockholders' equity at $90.43 million in 2023, indicating an improvement from negative equity in 2021. However, the debt-to-equity ratio is relatively low due to reduced total debt, suggesting limited leverage but also highlighting past reliance on external financing. The equity ratio shows a reasonable level of capitalization.
Cash Flow
20
Very Negative
Free cash flow is negative and deteriorating, with a significant drop from -$11.85 million in 2022 to -$29.9 million in 2023. Operating cash flow is also negative, indicating cash outflows from core operations. Despite substantial financing cash inflows, the cash flow situation remains weak, emphasizing cash burn issues.
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 Price154.02
Price Trends
50DMA
97.51
Positive
100DMA
81.59
Positive
200DMA
71.53
Positive
Market Momentum
MACD
11.79
Negative
RSI
74.58
Negative
STOCH
79.81
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 154.02 is above the 20-day moving average (MA) of 119.95, above the 50-day MA of 97.51, and above the 200-day MA of 71.53, indicating a bullish trend. The MACD of 11.79 indicates Negative momentum. The RSI at 74.58 is Negative, neither overbought nor oversold. The STOCH value of 79.81 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
$2.05B11.1825.93%21.13%50.86%
72
Outperform
$3.10B91.287.39%55.68%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
45
Neutral
$2.64B-44.44%-5.30%
44
Neutral
$2.44B-5.42-47.19%-84.07%-157.71%
43
Neutral
$3.62B-71.67-32.30%-73.27%
33
Underperform
$3.90B-60.45%117.83%-18.91%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BLTE
Belite Bio, Inc. ADR
154.02
89.02
136.95%
DNLI
Denali Therapeutics
18.16
-5.73
-23.98%
KNSA
Kiniksa Pharmaceuticals
40.93
19.76
93.34%
BEAM
Beam Therapeutics
24.05
-1.93
-7.43%
HRMY
Harmony Biosciences Holdings
35.51
1.01
2.93%
CNTA
Centessa Pharmaceuticals
28.47
11.35
66.30%
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: May 01, 2025