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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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Belite Bio, Inc. ADR

(NASDAQ:BLTE)

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 Trial Progress
The DRAGON trial is on track to be completed, potentially leading to a regulatory submission in Japan.
Financial Position
The company raised $15M in gross proceeds in a registered direct offering and ended the quarter with $157M in cash.
Regulatory Designation
Belite has announced it was granted FDA Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease, for which there are currently no approved treatments.
Negative Factors
Financial Performance
Net loss was $14.3M, moderately higher than the estimated loss.
Trial Enrollment Concerns
The next major catalysts for the shares are enrollment of the DRAGON II study and completion of the DRAGON study by year-end 2025.

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

Belite Bio, Inc. ADR Business Overview & Revenue Model

Company DescriptionBelite Bio, Inc. ADR (BLTE) is a clinical-stage biopharmaceutical company focused on discovering and developing novel therapeutics to address significant unmet medical needs in the fields of ophthalmology and metabolic diseases. The company is engaged in developing innovative treatments aimed at improving patient outcomes, particularly in the areas of retinal degenerative diseases such as Stargardt disease and dry age-related macular degeneration.
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:May 14, 2025
(Q1-2025)
|
% Change Since: -1.63%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook for Belite Bio, with significant progress in clinical trials for Tinlarebant and a robust financial position. However, increased operating expenses and pending regulatory details introduce some uncertainty.
Q1-2025 Updates
Positive Updates
Promising Clinical Progress for Tinlarebant
The Phase 3 DRAGON trial for Tinlarebant showed promising interim results with the DSMB recommending submission for further regulatory review. The trial is on track for completion by the end of the year.
Strong Financial Position
Belite Bio reported a cash increase of $12.3 million for the quarter, leaving the company with $157.4 million in cash and equivalents. The company expects a full year cash runway to complete all current clinical trials.
Phase 3 PHOENIX Trial Advancements
The PHOENIX trial for geographic atrophy has enrolled 464 subjects with a total target of 500. Enrollment is expected to be completed in Q3 2025.
Low Withdrawal Rates in Clinical Trials
DRAGON trial showed less than a 10% overall withdrawal rate, and the PHOENIX trial's dropout rate is approximately 20%, which is lower than comparables.
Negative Updates
Increased Net Loss
Net loss for the quarter was $14.3 million, up from $7.9 million in the same period last year, primarily due to increased R&D and G&A expenses.
Regulatory Uncertainty
Pending meetings with the FDA and other regulatory agencies could impact the development plan for Stargardt disease, and potential changes in drug pricing policy under President Trump could pose challenges.
Increased Operating Expenses
Operating expenses are anticipated to rise throughout 2025 due to milestones in clinical trials, potentially impacting financial projections.
Company Guidance
During the Belite Bio First Quarter 2025 Earnings Call, the company provided several key metrics and updates regarding their clinical trials and financial standing. In the Stargardt disease program, the Phase 3 DRAGON trial, involving 104 subjects, has moved forward successfully with the Data Safety Monitoring Board (DSMB) recommending no changes to the trial size and suggesting data submission for regulatory review. The DRAGON 2 trial has enrolled 16 out of a targeted 60 subjects. For geographic atrophy, the Phase 3 PHOENIX trial has enrolled 464 subjects out of a planned 500, with full enrollment expected by Q3 2025. Financially, the company reported R&D expenses of $9.4 million and G&A expenses of $6.1 million for Q1 2025, resulting in a net loss of $14.3 million. Despite the increased expenses, primarily due to share-based compensation, Belite Bio maintains a strong financial position with $157.4 million in cash and equivalents, ensuring a cash runway to complete current clinical trials.

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 Profit0.00-449.00K-399.00K-198.00K-30.00K-17.00K
EBITDA-43.48M-35.67M-31.53M-12.43M-9.64M-5.71M
Net Income-42.10M-36.14M-31.63M-12.47M-9.79M-5.75M
Balance Sheet
Total Assets118.43M152.13M94.64M44.27M18.35M25.74M
Cash, Cash Equivalents and Short-Term Investments95.50M145.15M88.16M42.09M17.34M25.62M
Total Debt0.00537.00K886.00K866.00K31.81M31.81M
Total Liabilities3.84M6.31M4.21M2.77M33.44M32.78M
Stockholders Equity114.59M145.82M90.43M41.50M-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
Negative
Last Price59.90
Price Trends
50DMA
61.52
Negative
100DMA
61.24
Negative
200DMA
61.34
Negative
Market Momentum
MACD
-0.65
Positive
RSI
45.54
Neutral
STOCH
41.40
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BLTE, the sentiment is Negative. The current price of 59.9 is below the 20-day moving average (MA) of 61.82, below the 50-day MA of 61.52, and below the 200-day MA of 61.34, indicating a bearish trend. The MACD of -0.65 indicates Positive momentum. The RSI at 45.54 is Neutral, neither overbought nor oversold. The STOCH value of 41.40 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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
58
Neutral
$2.06B-31.51%
54
Neutral
$2.10B-86.10%29.32%-11.00%
51
Neutral
$7.41B0.32-61.11%2.34%16.99%1.69%
49
Neutral
$1.69B-33.98%449.03%42.86%
45
Neutral
$2.10B-35.21%-100.00%-144.79%
45
Neutral
$1.69B-38.04%-82.38%-164.76%
43
Neutral
$1.99B-33.43%4.80%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BLTE
Belite Bio, Inc. ADR
59.90
14.22
31.13%
DNLI
Denali Therapeutics
14.49
-8.73
-37.60%
BEAM
Beam Therapeutics
16.80
-6.63
-28.30%
TARS
Tarsus Pharmaceuticals
40.33
13.15
48.38%
NAMS
NewAmsterdam Pharma Company
18.45
-0.76
-3.96%
RXRX
Recursion Pharmaceuticals
5.40
-2.10
-28.00%
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