Outlook Therapeutics(US:OTLK)2024-12-27 13:14Product Development and Approvals - LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU and UK, with the first commercial launch anticipated in H1 CY25[2] - The company plans to resubmit the BLA for ONS-5010 in Q1 CY2025, with final efficacy data from NORSE EIGHT expected in January 2025[6][9] - Initial commercial launches of LYTENAVA™ in Europe are planned to commence in H1 CY2025[6] - Potential US FDA approval of ONS-5010 is anticipated in H2 CY2025[6] Financial Performance - Outlook Therapeutics had cash and cash equivalents of $14.9 million as of September 30, 2024[10] - The company reported a net loss of $75.4 million, or $4.06 per basic and diluted share, for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million, or $4.72 per basic and diluted share, for the prior fiscal year[18] - Research and development expenses increased to $41.8 million in FY2024 from $26.5 million in FY2023[23] - General and administrative expenses increased to $29.9 million in FY2024 from $26.7 million in FY2023[23] - Total assets decreased to $28.8 million as of September 30, 2024, from $32.3 million as of September 30, 2023[24] - Total stockholders' deficit increased to $73.1 million as of September 30, 2024, from $14.4 million as of September 30, 2023[24]