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Recent press releases and 8-K filings for OPT.

Opthea's Nasdaq Delisting Becomes Effective
OPT
Delisting/Listing Issues
  • Opthea Limited's voluntary delisting of its American Depositary Shares (ADSs) from The Nasdaq Global Select Market has become effective.
  • The company intends to file a Form 15F with the SEC to deregister and terminate its reporting obligations, with deregistration expected to be effective 90 days after the filing.
  • Opthea's ordinary shares will remain listed on the Australian Securities Exchange (ASX), serving as its primary trading market, although trading is currently suspended by the ASX.
  • Following the Nasdaq delisting, Opthea's ADSs may be traded by brokers and dealers through the U.S. Over-The-Counter (OTC) market.
Nov 20, 2025, 9:02 PM
Opthea Limited Reports Q1 FY26 Financials, Reduced Operating Costs, and Ongoing Strategic Review
OPT
Earnings
Delisting/Listing Issues
New Projects/Investments
  • Opthea Limited reported US $17.8 million in cash and equivalents as of September 30, 2025, a decrease from US $48.4 million at June 30, 2025. The company's operating cash outflow for Q1 FY26 was US $10.6 million, a significant reduction from US $53.6 million in the prior quarter.
  • This reduction in operating cash outflow was primarily due to an 80% decline in research and development expenditure to US $8.3 million and a 94% fall in personnel costs to US $0.8 million.
  • The company completed a binding settlement with Development Funding Agreement (DFA) investors, which included a US $20.0 million repayment of borrowings, eliminating a major liability.
  • Opthea is currently undertaking a strategic review of its internal assets, intellectual-property holdings, and potential partnerships to determine the optimal path for shareholder value creation, with an update intended later in 2025.
  • The estimated quarters of funding available are 1.7, although the company expects future cash burn to decrease significantly due to the discontinuation of development programs and the DFA settlement. Trading in the company's securities remains suspended by the ASX.
Oct 31, 2025, 1:28 PM
Opthea Announces Voluntary Nasdaq Delisting
OPT
Delisting/Listing Issues
  • Opthea Limited (ASX/NASDAQ: OPT) has announced its intention to voluntarily delist its American Depositary Shares (ADSs) from The Nasdaq Global Select Market.
  • This decision is due to the company no longer meeting Nasdaq's audit committee composition requirements and is part of a strategy to streamline global operations, reduce expenditure, and improve capital efficiency by consolidating its primary listing on the Australian Securities Exchange (ASX).
  • Opthea anticipates filing a Form 25 with the U.S. Securities and Exchange Commission (SEC) around November 10, 2025, with the last day of trading of its ADSs on Nasdaq expected to be on or about November 19, 2025.
  • The company's ordinary shares will remain listed on the ASX, which will be its primary trading market, though trading is currently suspended by the ASX.
  • Following the Nasdaq delisting, Opthea plans to maintain its American Depositary Receipt (ADR) program to facilitate continued holding and trading of its securities by U.S. investors through the U.S. Over-The-Counter (OTC) market.
Oct 30, 2025, 12:00 PM
Opthea Limited Provides Update on Sozinibercept Phase 3 Trials and Financial Position
OPT
Product Launch
New Projects/Investments
Guidance Update
  • Opthea Limited is advancing Sozinibercept, a first-in-class VEGF-C/D trap inhibitor for wet age-related macular degeneration (wet AMD), designed to improve vision when combined with existing anti-VEGF-A therapies.
  • Top-line Phase 3 results for the COAST trial are expected in early Q2 2025, followed by the ShORe trial readout mid-2025.
  • The company reported $130 million in cash at the end of December and has sufficient cash to fund operations until Q3 2025.
  • Opthea anticipates submitting its Biologics License Application (BLA) in early 2026, with potential FDA approval by the end of 2026 due to its Fast Track designation.
  • Sozinibercept targets the $12 billion worldwide wet AMD market by offering a complementary treatment that does not directly compete with existing anti-VEGF-A drugs.
Feb 11, 2025, 3:00 PM
Opthea Provides Update on Sozinibrecept Phase 3 Trials and Financial Position
OPT
New Projects/Investments
Guidance Update
Product Launch
  • Opthea is advancing Sozinibrecept, a first-in-class VEGF-C/D trap inhibitor for wet age-related macular degeneration (AMD), designed to be used in combination with existing anti-VEGF-A therapies to improve vision outcomes.
  • As of the document's publication date (February 11, 2025), top-line Phase 3 results for the COAST trial were expected in early Q2 2025, and the SHORE trial readout was anticipated mid-2025.
  • The company reported $130 million in cash at the end of December 2024, with a cash runway expected to last until Q3 2025.
  • A Biologics License Application (BLA) submission is projected for early 2026, with potential FDA approval by end of 2026 due to fast track designation.
  • The global wet AMD market is estimated at $12 billion, and surveyed payers indicated comfort with a price range of $1,800-$2,600 per injection for Sozinibrecept.
Feb 11, 2025, 3:00 PM
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