Opthea Limited (OPT): Business Model Canvas [Dec-2025 Updated]

You're looking at Opthea Limited right now, and honestly, the story isn't about blockbuster drug launches anymore; it's a sharp pivot to capital preservation after a massive US$126.832 million R&D spend in FY2025, following a 65% staff reduction in May. As a former BlackRock analyst, I see a company focused on winding down trials, cutting costs significantly, and managing its remaining US$20 million in cash while planning a Nasdaq delisting. This Business Model Canvas lays out the stark reality: key activities now center on maintaining IP and managing the transition, not patient recruitment. Dive in below to see exactly how Opthea Limited is restructuring its entire operation to secure shareholder value through this strategic shift.

Opthea Limited (OPT) - Canvas Business Model: Key Partnerships

You're looking at the critical relationships Opthea Limited maintained as it navigated the post-Phase 3 trial landscape in late 2025. These partnerships, especially the one with the DFA Investors, fundamentally reshaped the company's structure and immediate path forward.

DFA Investors (Ocelot SPV LP and Sanba II) as New Equity Holders

The relationship with Ocelot SPV LP and Sanba II Investment Company, the two DFA Investors, culminated in a significant settlement following the March 2025 decision to discontinue sozinibercept development in wet AMD. This move avoided potential termination payments that could have reached up to USD680 million. The final binding agreement terminated the Development Funding Agreement (DFA), which had originally provided a total of USD170 million in funding.

The consideration for this termination was a combination of cash and a substantial equity issuance, effectively making them new, significant equity holders.

These Subscription Shares rank equally with existing ordinary shares, solidifying their position as major shareholders post-settlement. Honestly, settling this agreement was a clear move to preserve cash and remove material uncertainty regarding Opthea's ability to continue as a going concern.

Contract Research Organizations (CROs) for Clinical Trial Wind-Down

With the development program discontinued, a key partnership activity involved the wind-down of the COAST and ShORe pivotal clinical trials. This required significant, albeit temporary, expenditure with Contract Research Organizations (CROs) and other service providers.

The operational impact is clear in the Q4 FY25 figures:

• Net operating cash outflow for the period ending June 30, 2025, was US$53.5m.
• Operational spend for the quarter was US$52.9m, primarily for closing out the two pivotal clinical trials.
• Research and development costs for Q4 FY25 hit US$39.8m.
• This R&D spend represented a 156% increase over the prior quarter's R&D spend of US$25.5m.

Opthea confirmed that during Q4 FY25, the company negotiated the termination of all contracts associated with the ShORe and COAST clinical trials. That's a major step in reducing future burn.

Australian Taxation Office for R&D Tax Incentives

The partnership with the Australian Taxation Office via the R&D Tax Incentive program provided a crucial, non-dilutive cash inflow in late 2025. This program offers cash incentives for 43.5% of eligible research and development expenditure.

The A$10.8 million received in October 2025 was disclosed as a current tax receivable in the June 30, 2025, audited financial statements. This cash helped bridge the gap following the significant operational spend.

Contract Development and Manufacturing Organizations (CDMOs) for Asset Maintenance

While the primary focus shifted to wind-down, the need for asset maintenance, particularly related to the sozinibercept candidate, implies ongoing, albeit reduced, engagement with Contract Development and Manufacturing Organizations (CDMOs). Prior to the wind-down, the cash runway forecast through Q3 2025 was explicitly subject to assumptions regarding CDMO costs.

Post-settlement, the focus shifts to managing remaining assets, which means CDMOs are likely involved in preservation or transfer activities, though specific 2025 financial figures for ongoing maintenance contracts aren't explicitly detailed post-June 2025. We do know that personnel costs, which support oversight of these external partners, saw a massive spike in Q4 FY25:

• Personnel costs in Q4 FY25 were US$13.8m.
• This was a 226% increase over Q3 FY25 costs of US$6m.

Finance: draft 13-week cash view by Friday.

Opthea Limited (OPT) - Canvas Business Model: Key Activities

You're navigating the aftermath of pivotal trial results, so the key activities for Opthea Limited as of late 2025 pivot entirely around corporate restructuring and asset preservation. The focus is sharp: cut costs, simplify structure, and manage the wind-down of the sozinibercept development program.

Terminating all contracts for the COAST and ShORe Phase 3 trials was a major operational activity following the March 2025 decision to discontinue sozinibercept development in wet AMD after primary endpoints were not met in both trials. This termination was formalized during the Quarter 4 Fiscal Year 2025 (Q4 FY25), allowing the company to cease incurring material expenses associated with those programs in future quarters.

Conserving cash and streamlining corporate structure involved significant reductions. Opthea Limited executed a reduction in staff of approximately 85%. This streamlining was also a primary driver for managing the voluntary delisting from Nasdaq, which became effective on November 21, 2025. The company filed a Form 15F with the Securities and Exchange Commission (SEC) to terminate its reporting obligations, aiming to reduce expenditure and simplify governance associated with maintaining a dual listing. The anticipated last day of trading for American Depositary Shares (ADSs) on Nasdaq was on or about November 19, 2025.

The company was conducting an internal strategic review of remaining assets, with an expected update to investors later in 2025, following the completion of the Development Funding Agreement (DFA) settlement. This review is critical given the prior uncertainty regarding the ability to continue as a going concern.

The table below summarizes the financial and structural shifts that define these key activities:

The final required activity centers on maintaining intellectual property portfolio for sozinibercept. While development was discontinued, the company's stated intention is to position itself to concentrate on developing a clear forward strategy built on its scientific strengths. This implies the necessary legal and administrative steps are being taken to preserve the patent estate surrounding OPT-302, the VEGF-C/D inhibitor.

Key structural changes tied to these activities included executive departures:

• CEO Frederic Guerard to depart on September 1^st, 2025.
• CFO Tom Reilly and Director Sujal Shah to step down.
• Dr. Jeremy Levin continues as Executive Chairman.

The company's ordinary shares remain listed on the Australian Securities Exchange (ASX), which is now the primary trading market. Finance: draft 13-week cash view by Friday.

Opthea Limited (OPT) - Canvas Business Model: Key Resources

You're looking at the core assets Opthea Limited is relying on to navigate its post-Phase 3 landscape as of late 2025. Honestly, the key resources now are heavily weighted toward intangible assets and lean operational capacity, given the recent strategic shifts.

The financial runway is tight but managed following the DFA settlement. Here's the quick math on the cash position and governmental support.

The R&D Tax Incentive is a critical cash inflow, representing 43.5% of eligible expenditure for the development of sozinibercept under the Australian Federal Government program.

The most significant resource is the intellectual property surrounding its lead candidate, sozinibercept (OPT-302).

• Mechanism: Novel recombinant "trap" fusion protein targeting inhibition of VEGF-C and VEGF-D.
• Function: Designed to block and isolate VEGF-C and VEGF-D from activating VEGF receptors 2 and 3 when combined with a VEGF-A inhibitor.
• Patent Coverage: Issued patents run to at least 2034, with pending patents expected to extend coverage further.

The team structure has been drastically altered to conserve cash following the termination of the Phase 3 trials in March 2025. This was a major restructuring of the human capital base.

The initial workforce reduction was substantial:

• Reduction Percentage (Effective May 1, 2025): Approximately 65%
• Purpose: To reduce the cost base and conserve cash following negative Phase 3 trial results.
• Resulting Monthly Cost Reduction: Approximately US$1 million in monthly employee costs.

To be fair, subsequent announcements indicated an even leaner structure was adopted by August 2025, including executive departures. A limited number of employees remained post-May 1 to manage clinical trial termination and administration. Key executive changes included the departure of the CEO and CFO on September 1, 2025, with Dr. Jeremy Levin continuing as Chairman and taking on additional CEO responsibilities as a consultant.

The remaining core team is focused on administration and reviewing internal assets, including intellectual property, to determine the optimal path for shareholder value creation.

Finally, eligibility for the Australian R&D Tax Incentive program remains a key operational resource, providing a direct cash benefit for past R&D expenditure on sozinibercept.

Finance: draft 13-week cash view by Friday.

Opthea Limited (OPT) - Canvas Business Model: Value Propositions

You're looking at the core value being offered to shareholders now that the primary development program has concluded. The value proposition has shifted from potential drug success to financial restructuring and asset preservation.

Preserving remaining shareholder capital through cost-cutting and delisting

The immediate value proposition centers on aggressive cost management to maximize the remaining cash runway. This involved significant operational streamlining following the March 2025 decision to discontinue the wet AMD trials.

Opthea Limited executed a workforce reduction of over 80%, with initial layoffs of approximately 65% taking effect on May 1, 2025. This action resulted in a reduction in monthly employee costs of approximately USD 1 million. The company is consolidating its listing to preserve capital, intending to file a Form 15F with the SEC to terminate reporting obligations after the American Depositary Shares (ADSs) delist from The Nasdaq Global Select Market on or about November 19, 2025.

The impact on operating expenses is clear when comparing the quarters:

The quarterly operating cash outflow also decreased substantially, from USD 53.5 million in Q4 FY25 to USD 10.6 million in Q1 FY26.

Potential for a new pipeline asset from scientific strengths (future value)

Despite the discontinuation of the sozinibercept wet AMD program, the underlying scientific platform remains a source of potential future value. The company is actively reviewing its internal assets and intellectual-property holdings to determine the optimal path for shareholder value creation.

The scientific strength is underscored by prior regulatory recognition:

• Sozinibercept was granted 'Fast Track' designation by the US Food and Drug Administration in 2021.
• The company is investigating the feasibility of a co-formulation of sozinibercept with a VEGF-A inhibitor.
• An update on the strategic review is intended later in 2025.

Clean resolution of the Development Funding Agreement (DFA) obligation

A critical component of the current value proposition is the elimination of a massive contingent liability through a negotiated settlement with the DFA Investors (Ocelot SPV LP and Sanba II Investment Company).

The settlement agreement, reached in August 2025, removed the risk of potential payments up to USD 680 million. This clean resolution was key to Opthea remaining solvent.

The financial impact of the DFA settlement and subsequent restructuring is reflected in the cash position:

The company expects its cash position to strengthen materially in the next reporting period through the receipt of an R&D tax incentive, announced on October 6, 2025.

Opthea Limited (OPT) - Canvas Business Model: Customer Relationships

Investor relations focused on transparency and strategic updates involved communicating the outcome of the Phase 3 trials and the subsequent financial restructuring.

Opthea Limited hosted a webcast on August 19, 2025, to discuss the Development Funding Agreement (DFA) settlement and future plans following the August 2025 agreement. Prior to this, management hosted Investor Days in New York City on January 28, 2025, and in Sydney and Melbourne on February 3 and February 5, 2025, respectively, to update on commercial readiness plans. Trading in Opthea Limited securities remained suspended by ASX and NASDAQ pending clarity on the financial position after the trial failures. The company reported unaudited cash and cash equivalents of US$101.4 million at the end of March 2025, before the settlement payment. Cash at June 30, 2025, was US$48.4 million. The net operating cash outflow for the quarter ending June 30, 2025, was US$53.5 million.

Regulatory compliance for clinical trial termination involved specific actions taken after the COAST and ShORe Phase 3 trials did not meet their primary endpoints in March 2025. The decision was made in consultation with the DFA Investors to discontinue the development of sozinibercept in wet AMD with immediate effect. A limited number of employees remained in place to ensure the compliant termination of clinical trial activities and oversee administration operations.

The company executed significant operational changes to manage the wind-down and conserve cash, which required communication with stakeholders regarding regulatory closure obligations. These steps included:

• Workforce reduction of approximately 65% effective May 1, 2025.
• One-off cost associated with the reduction in force was approximately US$4.5 million.
• Monthly employee costs decreased by approximately US$1 million following the reduction.
• Research and development costs for Q4 FY25 were US$39.8 million.
• Personnel costs in Q4 FY25 were US$13.8 million, up 226% on the previous quarter's US$6 million.

Direct communication with DFA Investors, who became significant shareholders post-settlement, was critical to avoiding insolvency and securing the company's immediate solvency. The August 2025 settlement avoided a potential liability of up to USD680 million under the original DFA terms. The terms of the settlement reset the relationship, with the DFA Investors receiving equity consideration for terminating the agreement.

The key financial and equity terms of the DFA settlement with DFA Investors are summarized below:

The settlement agreement, entered into by Opthea Limited and Ocelot SPV LP and Sanba II Investment Company, resulted in the release of all liens on collateral. The remaining USD20 million cash position provides runway for a strategic review over the next six months, with Dr Jeremy Levin continuing as Chairman and assuming CEO responsibilities as of September 1, 2025.

Opthea Limited (OPT) - Canvas Business Model: Channels

You're looking at how Opthea Limited communicates with and provides access to its securities for investors as of late 2025. The channel strategy has recently undergone a significant shift, moving away from a dual listing structure to consolidate on its home market while maintaining a path for US shareholders.

The primary listing venue remains the Australian Securities Exchange (ASX), trading under the ticker OPT. As of the last reported price snapshot near the end of the year, the previous closing price was $0.60. The company has 1,367,978,173 shares issued, resulting in a market capitalization of approximately $820,786,904 based on that closing price. It is important to note that trading on the ASX was suspended under ASX Listing Rule 17.3 at the time of the delisting announcement. The 52-week trading range for OPT leading up to March 2025 spanned from a low of $0.59 to a high of $1.17.

For US investor trading, the channel has transitioned following the voluntary delisting from Nasdaq, which became effective around November 20, 2025. Opthea Limited now intends for its American Depositary Shares (ADSs) to trade through the U.S. Over-The-Counter (OTC) market. This trading occurs on the Pink Limited Market, which is noted for having limited to no issuer involvement and requires an initial review by a broker-dealer under SEC Rule 15c2-11 for continuous market making. As of November 28, 2025, the best bid on the OTC market (ticker OPTEY) was 0.1055, with a daily trading volume of 16,925 shares.

Here's a quick look at the key market metrics for these channels as of late 2025:

Corporate announcements and investor briefings serve as the direct communication channels to keep the market informed, especially following the pivotal decision to discontinue the wet AMD trials in March 2025. The company is now focused on a strategic review.

Key communication events in the latter half of 2025 included:

• The announcement of the voluntary delisting from Nasdaq on October 30, 2025.
• The 2025 Annual General Meeting held on November 11, 2025.
• A Virtual Business Update on August 19, 2025, detailing the Development Funding Agreement (DFA) settlement.
• The DFA settlement itself, which concluded on August 19, 2025, leaving the company with approximately USD20M in cash equivalents.
• The company expects to update investors later in 2025 on the outcomes of its internal review of programs and assets.

The company is simplifying its structure to preserve capital, which includes filing a Form 15F to terminate its reporting obligations under the Securities Exchange Act of 1934, expected to be effective 90 days after filing. Finance: draft the cash flow projection based on the $17.863 million Q3 2025 cash balance by Monday.

Opthea Limited (OPT) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Opthea Limited (OPT) after the significant pivot following the March 2025 termination of the sozinibercept wet AMD program. The focus has shifted from active drug development to corporate restructuring and maximizing residual value for stakeholders.

Existing institutional and retail shareholders seeking a turnaround or asset play

This segment is highly engaged, given the recent corporate events, including the failure of the Phase 3 COAST and ShORe trials and the subsequent restructuring. The primary focus for the remaining Board, as of the November 11, 2025, Annual General Meeting, is maximizing shareholder value, with resolutions carried by requisite majorities, such as the re-election of Director Dr. Jeremy Levin with 87.41% of votes cast for.

The financial context for this segment is defined by the August 2025 settlement of the Development Funding Agreement (DFA) with the DFA Investors. This settlement was crucial, as certain termination events could have triggered payments up to USD680 million. The final terms involved the DFA Investors receiving a one-time payment of $20 million and equity equivalent to 9.99% of the total issued share capital, represented by 136,661,003 fully paid ordinary shares. This action helped ensure Opthea Limited remained solvent, with estimated unaudited cash and cash equivalents of approximately USD20 million as at the Effective Date of the settlement. For the fiscal year ended June 30, 2025, Opthea Limited reported a net loss per share of $0.1329.

Key financial metrics relevant to shareholder value perception:

Former clinical trial sites and investigators (for closure and data management)

This group consists of the global sites that conducted the COAST and ShORe trials, which involved close to 2,000 patients in over 300 global sites. Following the termination of the wet AMD program in March 2025, the operational focus shifted to compliant closure. The initial workforce reduction of approximately 65% effective May 1, 2025, was specifically designed to leave a limited number of employees to ensure the compliant termination of clinical trial activities. This restructuring was projected to save about US$1 million per month in employee costs. By August 2025, the workforce reduction was stated to be over 80%.

• Workforce reduction percentage: 65% initially, later over 80%
• Workforce reduction effective date: May 1, 2025
• One-off cost for reduction: Estimated at $4.5 million
• Monthly cost savings projected: Approx. US$1 million

Potential future partners for new drug candidates

With the sozinibercept retinal program discontinued, the remaining Board is assessing the path forward. The August 2025 corporate update indicated that the Board will assess strategic partnerships or potential business development (BD) / licensing opportunities. This segment is currently speculative, as the company's primary asset development ceased, but the assessment is a formal part of the post-restructuring strategy.

The assessment priorities for the Board include:

• Full strategic review over the next six months
• Targeted internal development
• Strategic partnerships or potential BD/Licensing, where appropriate
• Return of capital to shareholders, where appropriate

Opthea Limited (OPT) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Opthea Limited (OPT) as the company pivots following the Phase 3 trial outcomes and subsequent restructuring in 2025. The focus has sharply shifted from high-burn clinical development to cash preservation and streamlined administration. Here's the quick math on where the costs are now concentrated.

The largest historical cost component, Research and Development (R&D), is now being finalized. The total R&D expenses for the fiscal year ending June 30, 2025, were reported as US$126.832 million. This figure reflects the substantial spend leading up to and including the conclusion of the COAST and ShORe trials.

The cost structure is now dominated by wind-down activities and necessary administrative overhead. The company took decisive action to reduce its operating base, which involved significant one-off expenditures to realize future savings.

• R&D wind-down costs included termination fees and final trial expenses related to the discontinued sozinibercept program.
• The initial workforce reduction, effective May 1, 2025, carried one-off costs estimated at approximately US$4.5 million.
• The operational spend in the fourth quarter of FY25 alone included approximately $50 million attributed to concluding the two pivotal clinical trials and the associated reduction in force of about 85%.
• A binding agreement to settle the Development Funding Agreement (DFA) required a one-time payment of USD20 million to the DFA Investors.

The primary goal of these actions was to slash recurring personnel costs. The workforce reduction, which ultimately saw a reduction of approximately 80% in staff, was projected to yield substantial monthly savings. This translates directly to a reduced personnel cost base, saving approximately US$1 million per month starting from May 2025.

Administrative and compliance costs are now centered on maintaining the company's presence in Australia. To improve capital efficiency, Opthea Limited announced its intention to voluntarily delist its American Depositary Shares from Nasdaq. This move directly targets the reduction of expenditure associated with maintaining a dual listing, acknowledging that the 'cost and regulatory and administrative demands of maintaining a dual listing are significant.' A limited number of employees remain in place specifically to oversee these ongoing administration operations and ensure compliant termination of remaining clinical trial activities.

To give you a clearer picture of the major cost elements following the major restructuring events, here is a breakdown of the key financial figures related to the wind-down and ongoing structure:

The company is now focused on fiscal discipline while pursuing the best path forward for its remaining assets. Finance: draft 13-week cash view by Friday.

Opthea Limited (OPT) - Canvas Business Model: Revenue Streams

You're looking at the revenue picture for Opthea Limited (OPT) as of late 2025, which, frankly, is dominated by non-operational, non-sales related cash inflows following the strategic pivot away from the lead candidate.

Australian R&D Tax Incentive Receipts

The most significant recent cash event was the receipt of the Australian Research and Development (R&D) tax incentive payment, a crucial non-dilutive source of funding for eligible R&D expenditure. This payment relates to costs incurred during the 2024/2025 financial year.

• Amount Received: $\text{US\$7.2 million}$ (equivalent to $\text{A\$10.8 million}$).
• Receipt Date: October 2025.
• Program Basis: Cash incentive for $\text{43.5\%}$ of eligible research and development expenditure.
• Expenditure Covered: Costs related to the development of sozinibercept.

Non-operating Income from Interest on Cash Holdings

While not a primary revenue driver, the interest earned on the company's cash reserves contributes to the non-operating income line. This is a direct function of the cash balance held, which was $\text{US\$48.4m}$ at June 30, 2025. The variability in these receipts is evident quarter-to-quarter; for instance, cash receipts in Q4 FY25 were $\text{US\$0.7m}$, which was $\text{62\%}$ of the $\text{US\$1.2m}$ received in the prior quarter, a consequence of the varying interest on cash holdings.

No Product Sales Revenue

As of the fiscal year ending June 30, 2025, Opthea Limited has generated no revenue from the sales of approved products. This is the direct result of the decision to discontinue the development program for sozinibercept in wet age-related macular degeneration (AMD) after both the COAST and ShORe Phase 3 trials failed to meet their primary endpoints.

The revenue structure for the fiscal year ended June 30, 2025, reflects this reality, relying on nominal, non-core activities. You can see the breakdown here:

The $\text{\$25,000}$ in ordinary revenue for the 2025 fiscal year is derived from sales-based royalties related to out-licensing of intellectual property assets not central to the discontinued core business. Honestly, this is nominal income, not the engine of the business model anymore.