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Outlook Therapeutics(OTLK) - 2025 Q2 - Quarterly Results

Financial Performance - For the fiscal second quarter ended March 31, 2025, Outlook Therapeutics reported a net loss of 46.4million,or46.4 million, or 1.50 per share, compared to a net loss of 114.3million,or114.3 million, or 8.01 per share, for the same period last year[11]. - The adjusted net loss for the fiscal second quarter was 12.5million,or12.5 million, or 0.40 per share, down from an adjusted net loss of 22.1million,or22.1 million, or 1.55 per share, in the fiscal second quarter of 2024[11]. - For the three months ended March 31, 2025, the net loss attributable to common stockholders was 46.358million,comparedtoanetlossof46.358 million, compared to a net loss of 114.289 million for the same period in 2024, representing a 59.3% improvement[26]. - The adjusted net loss attributable to common stockholders (non-GAAP) for the three months ended March 31, 2025, was 12.450million,comparedto12.450 million, compared to 22.057 million in 2024, a reduction of 43.5%[26]. - The company reported a loss from operations of 12.391millionforthethreemonthsendedMarch31,2025,comparedtoalossof12.391 million for the three months ended March 31, 2025, compared to a loss of 18.940 million in the same period of 2024, a 34.5% decrease[26]. - The loss before income taxes for the six months ended March 31, 2025, was 28.977million,asignificantimprovementfrom28.977 million, a significant improvement from 125.464 million in the same period of 2024, representing a 77.0% reduction[26]. Cash and Assets - As of March 31, 2025, Outlook Therapeutics had cash and cash equivalents of 7.6million[13].Cashandcashequivalentsdecreasedto7.6 million[13]. - Cash and cash equivalents decreased to 7.556 million as of March 31, 2025, from 14.928millionin2024,adeclineof49.314.928 million in 2024, a decline of 49.3%[24]. - Total assets decreased to 19.075 million as of March 31, 2025, from 28.823millionin2024,adeclineof33.728.823 million in 2024, a decline of 33.7%[24]. - The total stockholders' deficit decreased to 32.463 million as of March 31, 2025, from 73.077millionin2024,reflectinga55.673.077 million in 2024, reflecting a 55.6% improvement[24]. Product Development and Regulatory Approvals - The FDA has set a PDUFA goal date of August 27, 2025, for the approval of ONS-5010 (bevacizumab-vikg) for the treatment of wet AMD[8]. - LYTENAVA™ is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the U.S. for retinal diseases[6]. - The BLA resubmission for ONS-5010 was based on data from the NORSE EIGHT trial, which demonstrated efficacy and safety for the treatment of wet AMD[9]. - If approved, ONS-5010/LYTENAVA™ will receive 12 years of regulatory exclusivity in the United States[8]. - The company may seek authorization for LYTENAVA™ in other European countries, Japan, and additional markets[7]. Strategic Collaborations and Launch Plans - The company is on track for the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following marketing authorizations granted in May 2024 and July 2024[3][4]. - Outlook Therapeutics has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals[7]. Research and Development Expenses - Research and development expenses for the six months ended March 31, 2025, were 14.067 million, down from 18.038millioninthesameperiodof2024,indicatinga22.018.038 million in the same period of 2024, indicating a 22.0% decrease[26]. - The company incurred warrant inducement expenses of 33.857 million for the three months ended March 31, 2025, compared to no such expenses in the same period of 2024[26].