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Outlook Therapeutics OTLK · USD

Health Care · US listing · 🇺🇸 United States

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0.46

+5.25%

Close of 9 Nov 2026, in USD

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About Outlook Therapeutics

From its filings with the US Securities and Exchange Commission

SEC filings

Outlook Therapeutics is based in Iselin, New Jersey and is incorporated in Delaware. Its shares trade on Nasdaq under the ticker OTLK. The SEC classifies its business as biological products, (no diagnostic substances). In the fiscal year to 30 September 2025, it reported revenue of $1.4m and a net loss of $62.4m. At that date it held total assets of $18.6m and shareholders' equity of −$32.2m.

In its own words

We are a biopharmaceutical company that has developed ONS-5010/LYTENAVATM as the first ophthalmic formulation of bevacizumab approved by the European Commission in the European Union, or EU, and the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom, or UK, for use in adults for the treatment of wet age-related macular degeneration, or wet AMD. In June 2025, we launched directly into the initial markets of Germany and the UK. Additionally, our Biologics License Application, or BLA, is currently under review at the U.S. Food and Drug Administration, or FDA, for the use of ONS-5010/LYTENAVA as a treatment for wet AMD in the United States. If approved by the FDA., our goal is to also launch directly in the United States as the first and only approved ophthalmic bevacizumab for the treatment of wet AMD. In addition to Europe and the United States., we may seek approval to launch ONS-5010/LYTENAVA the product in other markets. ONS-5010/LYTENAVA is manufactured in the United States.

Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. Prior to the approval of ONS-5010/LYTENAVA in the EU and UK, bevacizumab had only been approved for use in the treatment of various forms of cancer and had not been optimized for use in the treatment of retina diseases.

Quoted from its 10-K, filed 19 Dec 2025. Read the filing on SEC.gov ↗

Company facts

Sector
Health Care
Industry
Biotechnology
Listed since
13 Jun 2016
Employees
17
Head office
111 S. WOOD AVENUE, ISELIN, NJ, 08830
Incorporated in
DE
Classification
Biological Products, (No Diagnostic Substances)
Filer status
Non-accelerated filer<br>Smaller reporting company

Leadership

Pay as last reported

  • Mr. Faisal SukhtianIndependent Chairman of the Board$113,000
  • Mr. Robert JahrPresident, Chief Executive Officer, Director, since 2025
  • Mr. Lawrence KenyonChief Financial Officer, Executive Vice President, Treasurer, Company Secretary, Director, since 2015$634,597
  • Mr. Ralph ThurmanLead Independent Director, since 2018$242,500
  • Prof. Dr. Gerd AuffarthIndependent Director$79,000
  • Mr. Julian GangolliIndependent Director$112,500
  • Mr. Yezan HaddadinIndependent Director$110,000
  • Dr. Julia HallerIndependent Director$79,000
  • Mr. Kurt HilzingerIndependent Director$95,000
  • Mr. Andong HuangIndependent Director$75,000
  • Ms. Jenene ThomasInvestor Relations, since 2021

Environmental, social and governance

Scores out of 100, from our data supplier

ESG
Overall
22
Environment
20
Social
41
Governance
3
Carbon reduction policy
No
Human rights policy
No

SWOT analysis

AI-generated by our data supplier. Not written or checked by our editors.

AI-generated

Strengths

  • Outlook Therapeutics has FDA-approved ONS-5010/LYTENAVA for retinal indications including wet AMD and DME.
  • The company's BioSymphony Platform identifies eight biosimilar product candidates targeting immunology and oncology.
  • ONS-3010, an adalimumab biosimilar, has initiated Phase III preparatory activities for commercialization.

Weaknesses

  • Outlook Therapeutics employs only 14 full-time employees, limiting operational capacity.
  • The company's focus on biosimilars in immunology and oncology may face intense competition.
  • ONS-1050, a trastuzumab biosimilar, remains in preclinical development without FDA approval.

Opportunities

  • ONS-3010's Phase III preparatory activities could lead to FDA approval and market entry.
  • The growing demand for biosimilars in the US market presents expansion potential.
  • The BioSymphony Platform's eight product candidates offer multiple revenue streams.

Threats

  • The FDA approval process for biosimilars may delay market entry for ONS-3010 and ONS-1045.
  • Competition from established biopharmaceutical companies in the oncology sector.
  • The high costs of clinical trials for biosimilars could strain financial resources.

Sources and methodology

Data on this tab
Our data supplier
Chart on the Overview
TradingView

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