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Upturn AI SWOT - About
OTLK 
OUTLOOK THERAPEUTICS INC (OTLK)
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Upturn Advisory Summary
08/28/2025: OTLK (1-star) has a low Upturn Star Rating. Not recommended to BUY.
Upturn Star Rating
Not Recommended Performance
These Stocks/ETFs, based on Upturn Advisory, consistently fall short of market performance, signaling caution before investing.
Number of Analysts
6 Analysts rated it
Limited analyst coverage, niche firm, research info may be scarce.
1 Year Target Price $8.25
1 Year Target Price $8.25
| 4 | Strong Buy |
| 1 | Buy |
| 1 | Hold |
| 0 | Sell |
| 0 | Strong Sell |
Analysis of Past Performance
Type Stock | Historic Profit -73.17% | Avg. Invested days 30 | Today’s Advisory WEAK BUY |
Upturn Star Rating | Upturn Advisory Performance  2.0 | Stock Returns Performance  1.0 |
| Profits based on simulation | Last Close 08/28/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 37.81M USD | Price to earnings Ratio - | 1Y Target Price 8.25 |
Price to earnings Ratio - | 1Y Target Price 8.25 | ||
Volume (30-day avg) 6 | Beta 0.27 | 52 Weeks Range 0.79 - 8.32 | Updated Date 08/29/2025 |
52 Weeks Range 0.79 - 8.32 | Updated Date 08/29/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) -0.84 |
Earnings Date
Report Date 2025-08-14 | When - | Estimate -0.06 | Actual -0.55 |
Profitability
Profit Margin - | Operating Margin (TTM) -1046.2% |
Management Effectiveness
Return on Assets (TTM) -130.65% | Return on Equity (TTM) -3.65% |
Valuation
Trailing PE - | Forward PE 2.85 | Enterprise Value 63606794 | Price to Sales(TTM) 25.12 |
Enterprise Value 63606794 | Price to Sales(TTM) 25.12 | ||
Enterprise Value to Revenue 42.25 | Enterprise Value to EBITDA -4.13 | Shares Outstanding 44419500 | Shares Floating 25057945 |
Shares Outstanding 44419500 | Shares Floating 25057945 | ||
Percent Insiders 36.39 | Percent Institutions 20.53 |
Upturn AI SWOT
OUTLOOK THERAPEUTICS INC
Company Overview
History and Background
Outlook Therapeutics, Inc. was founded in 2003. Initially focused on oncology, it shifted to ophthalmology with a focus on treatments for retinal diseases. The company's lead product candidate is ONS-5010 / LYTENAVA (bevacizumab-vikg), an ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases.
Core Business Areas
- Ophthalmology: Focused on developing and commercializing ONS-5010 / LYTENAVAu2122 for various retinal diseases, primarily wet AMD. Core activity revolves around clinical trials, regulatory submissions, and eventual commercialization of ONS-5010.
Leadership and Structure
Russell Trenary is the President and CEO. The company operates with a functional organizational structure, focusing on research and development, clinical operations, regulatory affairs, and commercialization.
Top Products and Market Share
Key Offerings
- ONS-5010 / LYTENAVA (bevacizumab-vikg): An ophthalmic formulation of bevacizumab intended for intravitreal injection to treat wet AMD and other retinal diseases. Currently seeking FDA approval. Market share is currently 0 as it has no FDA approved drugs. Competitors include: Regeneron (Eylea, aflibercept), Roche/Genentech (Lucentis, ranibizumab), and Novartis (Beovu, brolucizumab).
Market Dynamics
Industry Overview
The ophthalmology market is growing, driven by an aging population and increased prevalence of retinal diseases like wet AMD and diabetic macular edema. There's a high demand for effective and safe treatments delivered via intravitreal injection. The market is dominated by a few large players but there are opportunities for new entrants.
Positioning
Outlook Therapeutics is positioned as a potential disruptor in the wet AMD market by offering an on-label bevacizumab, often used off-label currently. If approved, ONS-5010 / LYTENAVA could capture a significant portion of the market currently utilizing compounded bevacizumab.
Total Addressable Market (TAM)
The global wet AMD market is estimated to be in the billions of dollars. Outlook Therapeutics is positioned to address the portion of the market currently using off-label bevacizumab, aiming to offer a safer, on-label alternative.
Upturn SWOT Analysis
Strengths
- Focus on a single product addressing a significant market need.
- Potential to offer a cost-effective, on-label alternative to off-label bevacizumab.
- Experienced management team with a track record in ophthalmology.
- Clear regulatory pathway through 505(b)(2) approval process.
Weaknesses
- Reliance on a single product candidate.
- No currently marketed products and therefore no revenue.
- Dependence on successful FDA approval of ONS-5010.
- Limited financial resources compared to larger competitors.
Opportunities
- Potential to capture a significant share of the wet AMD market currently using off-label bevacizumab.
- Expansion into other retinal diseases beyond wet AMD.
- Partnerships with pharmaceutical companies for commercialization.
- Positive clinical trial results and FDA approval can lead to significant stock price increases.
Threats
- Regulatory hurdles and potential for FDA rejection.
- Competition from existing and emerging therapies for wet AMD.
- Patent challenges or intellectual property infringement.
- Potential delays or setbacks in clinical trials.
- Ability to raise additional capital to fund operations.
Competitors and Market Share
Key Competitors
- REGN
- RHHBY
- NVS
Competitive Landscape
Outlook Therapeutics faces intense competition from established players. Its competitive advantage lies in potentially offering a lower cost alternative, but it needs to overcome regulatory hurdles and demonstrate comparable efficacy and safety.
Growth Trajectory and Initiatives
Historical Growth: Limited growth as the company is pre-revenue.
Future Projections: Future growth is entirely dependent on the successful FDA approval and commercialization of ONS-5010 / LYTENAVA. Analyst estimates vary widely depending on approval prospects.
Recent Initiatives: Focus on completing clinical trials for ONS-5010 / LYTENAVA and preparing for potential commercial launch. Submitting the Biologics License Application (BLA) to the FDA.
Summary
Outlook Therapeutics is a pre-revenue company focused on gaining FDA approval for its lead product, ONS-5010. The company's success depends on positive regulatory outcomes and its ability to compete with established ophthalmology players. The biggest threat to the company is if it does not obtain FDA approval to sell it's drug. With current cash reserves the company will have a difficult time to commercialize its single drug if approved without additional funding.
Peer Comparison
Sources and Disclaimers
Data Sources:
- Company SEC Filings (10-K, 10-Q)
- Company Website
- Analyst Reports
Disclaimers:
The data and analysis provided are for informational purposes only and should not be considered investment advice. The pharmaceutical and biotech industries are inherently risky, and results are not guaranteed.
AI Summarization is directionally correct and might not be accurate.
Summarized information shown could be a few years old and not current.
Fundamental Rating based on AI could be based on old data.
AI-generated summaries may have inaccuracies (hallucinations). Please verify the information before taking action.
About OUTLOOK THERAPEUTICS INC
Exchange NASDAQ | Headquaters Iselin, NJ, United States | ||
IPO Launch date 2016-05-13 | President, CEO & Director Mr. Robert Charles Jahr | ||
Sector Healthcare | Industry Biotechnology | Full time employees 23 | |
Full time employees 23 | |||
Outlook Therapeutics, Inc., operates as a clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for ophthalmic indications. Its lead product candidate is ONS-5010, an ophthalmic bevacizumab product formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age-related macular degeneration and other retina diseases. Outlook Therapeutics, Inc. has collaboration agreements with Cencora. The company was formerly known as Oncobiologics, Inc. and changed its name to Outlook Therapeutics, Inc. in November 2018. Outlook Therapeutics, Inc. was incorporated in 2010 and is headquartered in Iselin, New Jersey.
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