Opthea (OPT) Nasdaq Delisting – Strategic Refocus

Opthea Limited (ASX: OPT) Announces Nasdaq Delisting to Focus on ASX Listing

Opthea Limited (ASX: OPT), a biopharmaceutical company with a market capitalisation of approximately A$150 million and 500 million shares on issue, has issued an ASX announcement regarding a strategic shift. The company confirmed its voluntary withdrawal from Nasdaq, whilst maintaining its primary listing on the Australian Securities Exchange. This Opthea Nasdaq delisting announcement, made on October 30, 2025, represents a deliberate capital preservation strategy. It aims to streamline operations and reduce the substantial costs associated with dual-listing requirements, aligning with the company’s reported cash position of approximately A$40 million as of 30 September 2025.

The company specialises in developing novel therapies targeting diseases mediated by Vascular Endothelial Growth Factors (VEGF) C and D. This decision stems from its inability to maintain an audit committee meeting Nasdaq’s composition requirements under Listing Rule 5605(c)(2). The move extends beyond mere regulatory compliance, reflecting a broader operational restructure aimed at enhancing capital efficiency and focusing resources on core development programmes.

Understanding the Opthea Nasdaq Delisting Decision

The Opthea Nasdaq delisting announcement outlines multiple strategic factors that influenced this pivotal decision. Opthea shares are expected to cease trading on Nasdaq following a structured timeline, with the final trading day anticipated on or about November 19, 2025.

Primary Compliance Trigger:

• Audit committee composition deficiency under Nasdaq Listing Rule 5605(c)(2).
• Inability to maintain the required independent director structure.
• Ongoing challenges in meeting dual-market governance requirements.

Strategic Business Rationale:
The company has determined that the substantial expenses associated with dual-listing requirements no longer justify the benefits given current market conditions and strategic priorities. These costs typically include enhanced reporting requirements, additional audit fees, complex regulatory compliance demands, and significant administrative burdens that divert management attention from core business activities.

Dr Jeremy Levin, Executive Chairman of Opthea, stated: “Opthea is taking decisive steps to streamline its business and focus resources on the next phase of its evolution. By consolidating our listing on the ASX, we are preserving capital, maintaining transparency for shareholders, and positioning the Company to concentrate on developing a clear forward strategy built on its scientific strengths.”

Furthermore, the decision aligns with trends within the Australian biotech sector, where several companies have reassessed the value proposition of maintaining dual listings during challenging market conditions. The estimated annual savings from delisting could exceed $1-2 million in compliance, audit, and administrative costs. This represents meaningful capital preservation for a development-stage biopharmaceutical company.

What Happens to Opthea Shares After Nasdaq Delisting?

For Australian Investors:

• No impact on ordinary share holdings or ownership structure.
• The ASX remains the primary trading venue with full liquidity.
• Standard ASX trading rules continue to apply without interruption.
• The current ASX suspension under Rule 17.3 remains in effect pending resolution.
• Continued access to all ASX-based trading platforms and services.

For US Investors:

• American Depositary Shares (ADSs) will cease trading on Nasdaq after November 19, 2025.
• The ADR programme will continue through the Over-The-Counter (OTC) market.
• Conversion options are available for investors wishing to hold ordinary shares directly.
• The Depository Bank will facilitate the transition to OTC trading.
• Investors retain flexibility in holding their securities.

Key Timeline for Investors:

• Form 25 filing with SEC: On or about November 10, 2025.
• Last trading day on Nasdaq: Expected November 19, 2025.
• Delisting effective date: Ten days after Form 25 filing.
• Form 15F deregistration filing: Following delisting.
• Complete SEC deregistration: 90 days after Form 15F filing.

Opthea has committed to maintaining its American Depositary Receipt programme, ensuring US investors can continue holding and trading securities through the OTC market. This approach preserves access for international investors whilst reducing the regulatory burden associated with full Nasdaq compliance.

How Will the Delisting Affect Opthea’s VEGF-Targeted Therapy Development?

What are VEGF C and D?

Vascular Endothelial Growth Factors C and D are specialised proteins that regulate lymphatic vessel and blood vessel formation. Unlike the more commonly known VEGF-A targeted by established drugs such as Avastin and Lucentis, VEGF-C and VEGF-D play crucial roles in:

• Lymphatic system development and maintenance.
• Immune system function and cellular trafficking.
• Tumour metastasis through lymphatic spread pathways.
• Inflammatory disease progression and resolution.
• Angiogenesis in specific tissue contexts.

This scientific focus positions Opthea in a less crowded therapeutic space compared to VEGF-A inhibitors, with potential applications spanning oncology, ophthalmology, inflammatory conditions, and cardiovascular diseases. The company’s research platform addresses significant unmet medical needs across multiple therapeutic areas.

The Opthea Nasdaq delisting announcement enables management to concentrate resources on advancing these specialised programmes without the distraction and expense of dual-market compliance. The streamlined structure allows for more agile decision-making and resource allocation focused solely on scientific and clinical advancement rather than regulatory administration.

What Does Opthea’s Strategic Review Include?

Opthea has initiated a comprehensive internal review of its programmes and assets, with investors expecting updates later in 2025. This review encompasses several critical assessment areas that will shape the company’s future direction.

Programme Assessment Areas:

• Clinical pipeline prioritisation based on resource allocation efficiency.
• Asset portfolio optimisation to focus on highest-value opportunities.
• Partnership and licensing opportunities for non-core assets.
• Capital allocation strategy for remaining development programmes.
• Potential strategic transactions or collaborations.
• Intellectual property portfolio evaluation and protection strategies.

The strategic review process creates a catalyst-rich environment for 2025, with multiple potential value-creation opportunities including programme prioritisation, strategic partnerships, asset monetisation, and development milestones. Investors should monitor announcements carefully as the company reveals outcomes from this comprehensive assessment.

The review reflects a disciplined approach to capital allocation that prioritises long-term shareholder value over maintaining operational structures that no longer serve the company’s strategic objectives. This capital management philosophy distinguishes Opthea from competitors who may continue resource-intensive dual listings without clear strategic benefits.

Will Opthea’s Delisting Strategy Create Shareholder Value?

The success of Opthea’s strategic refocus will largely depend on the outcomes of its comprehensive internal review and the company’s ability to advance its VEGF-C/D programmes efficiently with preserved capital resources.

Investment Thesis Strengthening:

• Strategic inflection point with clear management focus on shareholder value creation.
• Specialised therapeutic niche with significant unmet medical needs across multiple indications.
• Enhanced capital efficiency extending development runway by potentially 12-18 months.
• Upcoming catalysts from strategic review and programme updates expected in late 2025.
• Streamlined structure reducing operational complexity and overhead costs.
• Potential for strategic partnerships or licensing agreements to unlock asset value.

Risk Considerations:
Forward-looking statements in the Opthea Nasdaq delisting announcement highlight various risks including the inability to maintain ASX listing, changes in applicable laws and regulations, future capital requirements, and regulatory risks associated with drug development. The company’s Annual Report on Form 20-F filed with the SEC on September 15, 2025, contains detailed risk factors investors should carefully consider.

The decision to delist from Nasdaq, whilst maintaining the ADR programme for US investors, strikes a balance between cost reduction and market access. This appears strategically sound given current circumstances.

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