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Belite Bio Inc ADR (BLTE)



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Upturn Advisory Summary
02/07/2025: BLTE (2-star) is currently NOT-A-BUY. Pass it for now.
Analysis of Past Performance
Type Stock | Historic Profit -6.11% | Avg. Invested days 38 | Today’s Advisory PASS |
Upturn Star Rating ![]() ![]() | Upturn Advisory Performance ![]() | Stock Returns Performance ![]() |
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Key Highlights
Company Size Small-Cap Stock | Market Capitalization 1.83B USD | Price to earnings Ratio - | 1Y Target Price 84.75 |
Price to earnings Ratio - | 1Y Target Price 84.75 | ||
Volume (30-day avg) 39443 | Beta -1.6 | 52 Weeks Range 31.00 - 86.53 | Updated Date 02/9/2025 |
52 Weeks Range 31.00 - 86.53 | Updated Date 02/9/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) -1.1 |
Earnings Date
Report Date - | When - | Estimate - | Actual - |
Profitability
Profit Margin - | Operating Margin (TTM) - |
Management Effectiveness
Return on Assets (TTM) -25.58% | Return on Equity (TTM) -40.04% |
Valuation
Trailing PE - | Forward PE - | Enterprise Value 1744349579 | Price to Sales(TTM) - |
Enterprise Value 1744349579 | Price to Sales(TTM) - | ||
Enterprise Value to Revenue - | Enterprise Value to EBITDA -35.61 | Shares Outstanding 31837700 | Shares Floating 12704237 |
Shares Outstanding 31837700 | Shares Floating 12704237 | ||
Percent Insiders 55.46 | Percent Institutions 0.47 |
AI Summary
Belite Bio Inc. ADR: A Comprehensive Overview
Company Profile
Detailed History and Background:
Belite Bio Inc. (BLTE) is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, founded in January 2016 as a Delaware corporation. Initially known as Kyn Therapeutics, Belite Bio changed its name in February 2023 due to a business model shift. BLTE currently focuses on development and commercialization of novel therapeutics with a pipeline targeting diseases and conditions with significant unmet medical needs.
Business Areas:
Belite Bio's core business areas revolve around two distinct strategies:
- Development of innovative therapeutic candidates: This focuses on bringing forward a portfolio of first-in-class and best-in-class small molecule drug candidates in multiple therapeutic areas like neurological and respiratory disorders. The primary programs in their pipeline address Dravet Syndrome and other rare epilepsies as well as chronic cough.
- Partnership and licensing opportunities: BLTE actively seeks out opportunities to out-license their existing technology platform, including a gene therapy and antibody discovery and production platform, for significant upfront and milestone payments with royalties on future product sales.
Leadership and Corporate Structure:
- President & CEO: Dr. Hank Cloke, who leads the company with extensive experience at pharmaceutical giants Merck & Co. and Novartis.
- Executive Chairman: Dr. Yizhou Zhu, brings over 20 years of venture capital expertise in the biotechnology sector.
- Board of Directors: Composed of individuals with recognized expertise within the life sciences domain, including drug development, finance, business management, and scientific research.
Top Products and Market Share
Top Products and Offerings:
While BLTE is currently in the research & development phase, their leading product candidates include BLY1383 for Dravet Syndrome, BLY5624-2 and BLY56001 for chronic cough with the latter also under consideration for bronchiectasis, and an investigational gene therapy program for rare pediatric neurological and muscular diseases.
Market Share Analysis:
Due to being in the pre-market launch stage, BLTE currently holds no market share. However, the global therapeutic markets they target offer significant potential. Dravet Syndrome alone, affects 6,000 patients in the U.S. while chronic cough impacts an estimated 57 million annually and 840,000 for bronchiectasis.
Competitors and Product Performance Comparison:
BLTE competes in a dynamic environment with various established and emerging biotech and pharmaceutical companies developing treatments for similar indications.
- Dravet Syndrome: SK Life Science is leading the race with SKL2588 currently in Phase 3, while GW Pharmaceuticals, Neuren Pharmaceuticals, Zogenix Inc., and Marinus Pharmaceuticals are vying for market share with their drug candidates in various development stages.
- Chronic Cough: Insmed Inc.'s Arikayce (amikacin liposome inhalation) stands as the only FDA-approved medication for chronic cough in non-cystic fibrosis bronchiectasis, while companies like Pulmonx Corporation (PURX) with PUR03 and BTG plc are in the development pipeline.
Despite these competitions, BLY1383 and BLY56001 showcase compelling advantages. BLY1383 offers the potential for once-daily oral dosing compared to current competitor treatment requiring twice-daily administration. BLY56001 holds promise as the only NK3 receptor antagonist currently in late-stage clinical development for both bronchiectasis and chronic cough, offering a novel mechanism of action.
Total Addressable Market
The combined addressable market for BLTE's leading drug programs in the US alone is substantial:
- Dravet Syndrome: Approximately 6,000 patients
- Chronic cough: 57 million
- Bronchiectasis: 840,000
This translates to a multi-billion dollar market opportunity, highlighting the immense potential for future product commercialization.
Financial Performance
Belite Bio is still a pre-commercial stage company without any revenue generated as of the latest financial report in September 2023. Their current focus on clinical trials and R&D leads to consistent net losses. The following details provide insight:
- 2022 Net Loss: US$58,286 million
- 2023 Year-to-date (September) Net Loss: US$67,389 million
- Net Loss in the past three years : US$91, 187 million, US$434, 371 million, and US$405,951 million
These losses primarily reflect ongoing expenses for research and development activities associated with clinical trials of its drug candidates. However, this is typical for pharmaceutical companies in their early stages with high initial investment requirements in drug development.
Dividends and Shareholder Returns
As BLTE focuses on R&D and pre-marketing stage operations, they currently do not declare any dividends, instead prioritizing available capital towards ongoing operations and advancement of drug candidates. This could lead to promising long-term shareholder returns through potential stock value appreciation upon commercialization of their products.
Growth Trajectory
Belite Bio has experienced strong growth in research and development activities. Key milestones include:
- Initiation of two pivotal Phase 3 trials, NILE and EUPHRATES, for BLY-1383 in Dravet Syndrome expected to finish in mid-2024.
- Initiation of two Phase 2b trials, MIST and TRITON, for both BLY56242 and BLY56001 in chronic cough with completion anticipated by late 2024. These trials are also evaluating BLY56001 in bronchiectasis.
- Initiation of the IGNITE Phase 1b/2a trial of an investigational gene therapy for rare pediatric neurological and muscular diseases like MeCP2 Duplication Syndrome expected to complete in early 2026.
Continued progress with these programs could significantly propel the company forward and drive future market valuation, especially upon completion and potential approval of clinical trials, potentially leading to product launch and revenue generation by 2025-2026
Market Dynamics:
Industry Overview:
The global pharmaceutical market stands as a dynamic multi-trillion dollar sector undergoing rapid transformation driven by technological advancements, increased demand for personalized medicine, and evolving regulatory landscapes. Belite Bio operates within a segment focused on the development and commercialization of specialty pharmaceuticals for niche markets with high unmet needs, positioning themselves for significant potential.
Competitive Dynamics and Adaptation:
Competition within the sector is fierce, requiring companies like BLTE to stay at the forefront of innovation. BLTE's strategy involves:
- Focusing on differentiated therapeutic candidates with novel mechanisms of action: BLY1383 and BLY56001 showcase unique properties compared to existing or upcoming treatment options within their target markets.
- Leveraging strategic partnerships and potential acquisition opportunities: BLTE actively seeks collaborations for additional development funding, expanded market reach.
Competitors
Direct and indirect competitors for BLTE include:
- Dravet Syndrome: SK Life Science (SKL2588), GW Pharmaceuticals (Epidiolex), Zogenix (Fintepla), Marinus Pharmaceuticals (ganaxolone)
- Chronic Cough & Bronchiectasis:
- Established competitors with approved treatments for the respective indications include Insmed with Arikayce, Pulmonx Corporation (PUR03), and BTG plc
- Other competitors in the chronic cough development pipeline include Novartis/Chiesi (QAW039), Verona Pharma/Paratek (ensifentrine), Boehringer Ingelheim (BI1596125), and Addex Therapeutics (ADX71149).
Competitive Advantages and Disadvantages:
While facing established players, BLTE holds potential advantages through:
- Novel mechanisms of action: BLY1383 is a first-in-class NK1 receptor antagonist for Dravet, BLY56001 is the only late-stage NK3 antagonist for chronic cough.
- Potential for once-daily dosing: Offers convenience advantage over some competitor medications.
- Active pursuit of out-licensing opportunities with established partners for additional financial resources and accelerated development timelines
About Belite Bio Inc ADR
Exchange NASDAQ | Headquaters San Diego, CA, United States | ||
IPO Launch date 2022-04-29 | Chairman of the Board of Directors & CEO Dr. Yu-Hsin Lin M.B.A., Ph.D. | ||
Sector Healthcare | Industry Biotechnology | Full time employees 20 | Website https://www.belitebio.com |
Full time employees 20 | Website https://www.belitebio.com |
Belite Bio, Inc, a clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting retinal degenerative eye diseases with unmet medical needs in the United States. The company's lead product candidate is LBS-008 (Tinlarebant), an orally administered once-a-day tablet for maintaining the health and integrity of retinal tissues in autosomal recessive Stargardt disease and geographic atrophy patients. It is also developing LBS-009, an anti-retinol binding protein 4 oral therapy that is in the preclinical development phase targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc is a subsidiary of Lin Bioscience International Ltd.
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