Outlook Therapeutics(US:OTLK) Newsfilter·2024-05-15 21:00Core Insights - Outlook Therapeutics is progressing towards regulatory approval for ONS-5010, an ophthalmic formulation of bevacizumab for retinal diseases, with anticipated marketing authorization in the EU and UK [2][4][10] - The company reported a significant net loss of $114.3 million for the second quarter of fiscal year 2024, compared to a net loss of $6.7 million in the same period last year [12][13] - The NORSE EIGHT clinical trial is underway in the US, with topline data expected in Q4 2024, and the company plans to resubmit the ONS-5010 Biologics License Application (BLA) by the end of 2024 [2][6][7] Regulatory Progress - The company received a positive opinion from the CHMP for ONS-5010 in the EU, with a decision from the European Commission expected within approximately 67 days [5][9] - The marketing application for ONS-5010 has been submitted in the UK under the International Recognition Procedure, allowing reliance on the CHMP's positive opinion [10] - The FDA has agreed to a non-inferiority study for ONS-5010, which, if successful, will satisfy the requirement for a second adequate and well-controlled clinical trial [4][8] Financial Performance - For the fiscal second quarter ended March 31, 2024, the adjusted net loss attributable to common stockholders was $22.1 million, or $1.55 per share, compared to $6.7 million, or $0.52 per share, in the same quarter of the previous year [12][13] - The company closed private placements raising $65 million, with potential additional proceeds of up to $107 million from warrant exercises [14] - As of March 31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million [14][26] Clinical Development - The NORSE EIGHT trial involves approximately 400 newly diagnosed wet AMD subjects, with over 30% of required subjects currently enrolled [7] - The primary endpoint of the NORSE EIGHT trial is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 8 [7] - Full enrollment for the NORSE EIGHT trial is expected by Q3 2024, with topline results planned for Q4 2024 [6][7] Future Outlook - The company is planning for potential commercial launches of ONS-5010 in the EU and UK in Q1 2025, with FDA approval anticipated in 2025 [6][11] - Outlook Therapeutics aims to be the first to market with an approved ophthalmic formulation of bevacizumab for retinal diseases in the US, EU, and UK [11][20]