Failure Q&AQ F7: What happens if the Phase 3 trials for...

Failure Q&A

Q F7: What happens if the Phase 3 trials for Sozinibercept (OPT-302) are a failure?

A: If the Phase 3 trials for Sozinibercept fail to meet their primary or secondary endpoints, the consequences could be severe for Opthea:

• Share Price Impact: The company's share price would likely experience a significant drop, potentially falling to a fraction of its pre-trial value. Investor confidence would diminish, and the market would reassess the company's future prospects, leading to a sharp decline in the share price.
• Options Prices: In this scenario, it is highly likely that the exercise prices of options (such as OPTOA and OPTOB) will not be met. As a result, these options would lapse, becoming worthless, leading to a total loss for investors holding these options.

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Q F8: What if the Phase 3 trials show partial success or success only in limited patient groups?

A: If the Phase 3 trials result in partial success—meaning the drug is effective only in certain sub-groups of patients or achieves only some of its primary endpoints—the outcomes could be mixed:

• Share Price Impact: The share price may still decline, though less severely than in the case of a complete failure. The company's value would be reassessed based on the limited market potential of the drug. The share price could stabilize at a lower level, but the overall market sentiment would likely be negative.
• Options Prices: Similar to a complete failure, if the share price stabilizes well below the options' exercise prices, it is highly likely that these options (OPTOA and OPTOB) will also lapse, becoming worthless. The options would not be exercised, resulting in a total loss for option holders.

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Timeline of Opthea

Q: What is the timeline of key events and milestones for Opthea Limited?

A: Here is the timeline of key events and milestones for Opthea:

• 1984: Company Founded - Opthea Limited was originally established as Circadian Technologies Limited, focusing on biotechnology and life sciences.
• 2015: Company Rebranding - The company rebranded as Opthea Limited, shifting its focus primarily to developing treatments for retinal diseases such as Wet AMD.
• 2018-2020: Phase 1/2a Trials (Sozinibercept) - Early clinical trials began to assess the safety and efficacy of Sozinibercept (OPT-302) in combination with anti-VEGF therapies. Positive data from these early trials supported further development.
• 2021-2022: Phase 2b Trials (Sozinibercept) - Phase 2b trial commenced, enrolling 366 treatment-naive Wet AMD patients. Top-line data released showing a +5.7 letter improvement in BCVA at 24 weeks, leading to the initiation of Phase 3 trials.
• September 2023: Capital Raising - Opthea conducted a capital raising, issuing approximately 160 million shares to institutional investors and 16 million shares to retail investors at A$0.46 per share, raising a total of A$82 million.
• December 2023: Amendment of Development Funding Agreement (DFA) - Opthea amended its DFA with Carlyle/Abingworth, providing a total of US$170 million in non-equity funding.
• February 2024: Phase 3 COAST Trial Enrollment Complete - 998 patients enrolled in the COAST trial, focusing on combination therapy with Sozinibercept and Eylea.
• May 2024: Phase 3 SHORE Trial Enrollment Complete - 986 patients enrolled in the SHORE trial, focusing on Sozinibercept’s efficacy in a specific patient sub-group.
• June 2024: Capital Raising - Opthea conducted another significant capital raising, issuing new shares to raise approximately A$171.5 million, with a retail component expected to raise an additional A$55.9 million.
• April-May 2025: Top-line Data (COAST Trial) - Expected release of the 52-week safety and efficacy results from the COAST trial.
• June-July 2025: Top-line Data (SHORE Trial) - Expected release of the 52-week safety and efficacy results from the SHORE trial.
• September-December 2025: BLA Submission - Opthea could begin a rolling Biologics License Application (BLA) submission to the FDA, potentially leading to approval by mid to late 2026.
• September 2025: OPTOA Options Expiry - OPTOA options, with an exercise price of A$0.80 per share, will expire on this date.
• June 2026: OPTOB Options Expiry - OPTOB options, with an exercise price of A$1.00 per share, will expire on this date.
• Mid to Late 2026: a) FDA Approval: Potential FDA approval of Sozinibercept, allowing the drug to be marketed in the U.S.
  b) Capital Raising for Commercialization: Depending on the approval outcome, Opthea may conduct another capital raising to fund the commercialization and scale-up of Sozinibercept.
• Late 2026 - Early 2027: Commercialization (Sozinibercept) - Following FDA approval and necessary capital raising, Sozinibercept could begin entering the U.S. market.

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