MELBOURNE, Australia and PRINCETON, N.J.—Opthea Limited (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company developing therapies to treat progressive retinal diseases, including wet age-related macular degeneration (AMD), has announced financial results for the 12 months ended June 30, 2024. For the fiscal year ended June 30, 2024, the company reported a net loss of $220.2 million, an increase of 55 percent, compared with a net loss of $142.5 million for the fiscal year ended June 30, 2023. The company also reported completed enrollment in sozinibercept pivotal trials, a large phase 3 program in wet AMD.

“During the 2024 fiscal year, we made outstanding progress in advancing sozinibercept’s phase 3 wet AMD program,” said Frederic Guerard, PharmD, chief executive officer of Opthea. “We completed enrollment in both COAST and ShORe pivotal trials evaluating the superiority of sozinibercept combination therapy. We strengthened our balance sheet with nearly $300 million in financing proceeds, and expect existing cash and cash equivalents to fund the company through the anticipated topline data readouts of COAST in early Q2 calendar year 2025 and ShORe in mid calendar year 2025. The funds will also be used to progress chemistry, manufacturing, and controls (CMC) activities, biologics license application (BLA) preparations for FDA approval, and continue to ready our organization for a potential launch of sozinibercept in wet AMD.”

The company reported a 2024 fiscal year adjusted non-IFRS net loss of $174.0 million compared with adjusted non-IFRS net loss of $135.5 million year-over-year, a 28 percent increase. Operating expenses (research and development and administrative expenses) totaled $192.1 million, compared with $150.4 million last year, primarily driven by the advancement of sozinibercept’s global phase 3 pivotal clinical program and CMC activities, the company said.

Cash and cash equivalents on June 30, 2024 totaled $172.5 million, the company reported. Cash balance was reported to be approximately $207.3 million.