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Belite Bio, Inc. ADR (BLTE)
NASDAQ:BLTE
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Belite Bio, Inc. ADR
(NASDAQ:BLTE)
Rating:43Neutral
Price Target:―
Positive Factors
Clinical Trials
The pivotal DRAGON I trial of tinlarebant in Stargardt disease remains on track to complete with low dropout rates and no significant issues.
Financial Position
The company raised $15M in gross proceeds in a registered direct offering and ended the quarter with $149M in cash, indicating a strong financial position.
Regulatory Support
Tinlarebant has received fast track, rare pediatric disease, and orphan drug designations in the US and Europe for Stargardt disease.
Negative Factors
Clinical Trials Enrollment
The DRAGON II Phase 2/3 trial in Japan, US, and the UK has enrolled 17 subjects out of 60, indicating slower progress in clinical trial enrollment.
Market Competition
Tinlarebant is differentiated as a once daily oral tablet targeting earlier stage of dry AMD, making it distinct from other GA treatments but facing competitive challenges.
Belite Bio, Inc. ADR (BLTE) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.12B
Dividend YieldN/A
Average Volume (3M)46.32K
Price to Earnings (P/E)―
Beta (1Y)0.80
Revenue GrowthN/A
EPS Growth-26.26%
CountryUS
Employees25
SectorHealthcare
Sector Strength47
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.50
Shares Outstanding32,599,297
10 Day Avg. Volume47,070
30 Day Avg. Volume46,321
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap0.82
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-39.81
Forecast
1Y Price Target
$93.75Price Target Upside45.33% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
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:Aug 11, 2025
(Q2-2025)
| % Change Since: |
Next Earnings Date:Nov 18, 2025
Earnings Call Sentiment Neutral
The earnings call highlights significant regulatory and clinical progress for Tinlarebant, indicating a strong position in advancing treatments for Stargardt disease and geographic atrophy. However, financial losses and the potential for extended regulatory timelines pose challenges.Q2-2025 Updates
Positive Updates
Tinlarebant's Regulatory Advancements
Tinlarebant has been granted breakthrough therapy, rare pediatric disease, and Fast Track designations in the U.S., as well as Pioneer designation in Japan. It has also received orphan drug designation in the U.S., Europe, and Japan.
Progress in Clinical Trials
The Phase III DRAGON trial for Stargardt disease has proceeded without modifications, and Tinlarebant remains on track to complete the study in Q4 2025. The geographic atrophy study has completed enrollment with 529 subjects.
Strong Financial Position
The company raised $15 million in a registered direct offering, maintaining a cash runway of 4 years, which supports the completion of all three Phase III trials.
Negative Updates
Increased Net Loss
The net loss for Q2 2025 was $16.3 million, compared to $9.5 million for the same period last year, driven mainly by increased R&D and G&A expenses, including share-based compensation.
Uncertainty in FDA Approval Process
Although breakthrough status is granted for Tinlarebant, the FDA recommends completing the 24-month study for potential single study approval, adding uncertainty to the timeline for approval.
Company Guidance
In the Belite Bio Second Quarter 2025 Earnings Call, the company provided detailed guidance on its progress and financial standings. The focus was on the advancement of Tinlarebant, a potential first oral treatment for Stargardt disease and geographic atrophy, both of which are currently without approved therapies. Tinlarebant has received multiple designations, including Breakthrough Therapy and Fast Track in the U.S., and orphan drug status in the U.S., Europe, and Japan. The company is conducting two studies on Stargardt disease, the Phase III DRAGON trial and the Phase II/III DRAGON II trial. The DRAGON trial has progressed well, with the FDA recommending further regulatory review after an interim analysis. Additionally, the global Phase III study for geographic atrophy completed enrollment with 529 subjects. Financially, Belite reported R&D expenses of $11 million and G&A expenses of $6.5 million, resulting in a net loss of $16.3 million for Q2 2025. The company has $149.2 million in cash and expects a four-year cash runway, excluding commercialization costs, supported by a recent $15 million capital raise.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
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.10
Very Negative
Balance Sheet
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.30
Negative
Cash Flow
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.20
Very Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | -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 | -12.65M | -9.67M | -5.75M |
Balance Sheet | ||||||
| Total Assets | 118.43M | 152.13M | 94.64M | 44.27M | 18.35M | 25.74M |
| Cash, Cash Equivalents and Short-Term Investments | 95.50M | 145.15M | 88.16M | 42.09M | 17.34M | 25.62M |
| Total Debt | 0.00 | 537.00K | 886.00K | 866.00K | 31.81M | 31.81M |
| Total Liabilities | 3.84M | 6.31M | 4.21M | 2.77M | 33.44M | 32.78M |
| Stockholders Equity | 114.59M | 145.82M | 90.43M | 41.50M | -15.09M | -7.04M |
Cash Flow | ||||||
| Free Cash Flow | 0.00 | -29.39M | -29.90M | -11.85M | -7.55M | -4.46M |
| Operating Cash Flow | 0.00 | -29.23M | -29.84M | -11.46M | -7.47M | -4.44M |
| Investing Cash Flow | 0.00 | -110.57M | -63.00K | -394.00K | -56.00K | -20.00K |
| Financing Cash Flow | 0.00 | 83.59M | 75.96M | 36.96M | -583.00K | 28.06M |
Belite Bio, Inc. ADR Technical Analysis
Positive
64.51
Price Trends
63.43
Positive
62.23
Positive
63.03
Positive
Market Momentum
>-0.01
Positive
48.38
Neutral
48.31
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 64.51 is below the 20-day moving average (MA) of 66.82, above the 50-day MA of 63.43, and above the 200-day MA of 63.03, indicating a neutral trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 48.38 is Neutral, neither overbought nor oversold. The STOCH value of 48.31 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 | $2.14B | 12.26 | 27.58% | ― | 17.74% | 59.96% | |
71 Outperform | $2.48B | 815.09 | 1.03% | ― | 56.18% | ― | |
51 Neutral | $7.81B | -0.22 | -40.01% | 2.29% | 21.48% | -2.11% | |
45 Neutral | $2.29B | ― | -39.69% | ― | -100.00% | 1.62% | |
43 Neutral | $2.12B | ― | -37.34% | ― | ― | -26.26% | |
41 Neutral | $1.68B | ― | -41.94% | ― | -82.90% | -155.64% | |
33 Underperform | $2.25B | ― | -72.95% | ― | 117.83% | -14.45% |
* Healthcare Sector Average
Performance Comparison
BLTE
Belite Bio, Inc. ADR
64.51
15.83
32.52%
DNLI
Denali Therapeutics
15.65
-8.79
-35.97%
KNSA
Kiniksa Pharmaceuticals
33.50
6.76
25.28%
BEAM
Beam Therapeutics
16.85
-9.83
-36.84%
HRMY
Harmony Biosciences Holdings
37.97
1.99
5.53%
CNTA
Centessa Pharmaceuticals
16.56
3.06
22.67%
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.