Outlook Therapeutics Earnings Reports

Outlook Therapeutics posted $1.5M in revenue for Q3 2025 from initial European sales of LYTENAVA™, with a GAAP net loss of $20.2M. The company ended the quarter with $8.9M in cash and had 37M shares outstanding. The FDA PDUFA date for its lead asset is set for August 27, 2025.

Outlook Therapeutics, Inc. reported a net loss of $46.36 million for the three months ended March 31, 2025, a significant improvement from the $114.29 million net loss in the same period last year. The company's operating loss also decreased to $12.39 million from $18.94 million year-over-year. This improvement was primarily driven by a substantial gain from changes in the fair value of warrant liability and reduced research and development expenses, despite an increase in general and administrative costs.

Outlook Therapeutics reported a net income of $17.4 million, or $0.72 per share, for the fiscal first quarter ended December 31, 2024, compared to a net loss of $11.2 million, or $0.86 per share, for the same period last year. The company is preparing for the potential launch of LYTENAVA™ in Germany and the UK in the second quarter of calendar year 2025 and plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

Outlook Therapeutics reported a net loss of $75.4 million for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million for the prior fiscal year. The company had cash and cash equivalents of $14.9 million as of September 30, 2024. They are preparing for commercial launch in the UK and Germany, expected in the first half of calendar 2025, and plan to resubmit the BLA in the first quarter of calendar 2025.

Outlook Therapeutics reported a net income of $44.4 million for the third quarter of fiscal year 2024, with significant progress in clinical trials and regulatory approvals for LYTENAVA™ in the EU and UK.

Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or $8.01 per basic and diluted share, for the fiscal second quarter ended March 31, 2024. The company is progressing towards potential marketing authorization of ONS-5010 in the EU and has submitted a marketing application in the UK. The NORSE EIGHT clinical trial is advancing towards a topline data readout expected in the fourth quarter of calendar year 2024.

Outlook Therapeutics reported its financial results for the first quarter of fiscal year 2024. The company highlighted the FDA's agreement on the NORSE EIGHT trial protocol and progress in addressing CMC comments in the CRL. They also entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval.

Outlook Therapeutics reported its financial results for the fiscal year ended September 30, 2023, with a net loss attributable to common stockholders of $59.0 million and cash and cash equivalents of $23.4 million.

Outlook Therapeutics reported a net loss attributable to common stockholders of $20.7 million for the fiscal third quarter ended June 30, 2023. The company's cash and cash equivalents were $33.7 million as of June 30, 2023, expected to fund operations through the anticipated approval of the BLA for ONS-5010.

Outlook Therapeutics reported a net loss attributable to common stockholders of $6.7 million, or $0.03 per basic and diluted share, for the fiscal second quarter ended March 31, 2023. The company's cash and cash equivalents were $43.7 million as of March 31, 2023.

Outlook Therapeutics reported a net loss attributable to common stockholders of $18.7 million, or $0.08 per basic and diluted share, for the fiscal first quarter ended December 31, 2022. The company closed a registered direct equity offering and an unsecured convertible promissory note, resulting in net proceeds expected to support operations past the anticipated FDA approval of ONS-5010.

Outlook Therapeutics reported a net loss attributable to common stockholders of $66.1 million for the fiscal year ended September 30, 2022. The company had cash and cash equivalents of $17.4 million at the end of the fiscal year.

Outlook Therapeutics reported a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, for the fiscal third quarter ended June 30, 2022. The company had cash and cash equivalents of $26.0 million at June 30, 2022, which are expected to provide funding into the first calendar quarter of 2023. The company is focused on resubmitting the BLA for ONS-5010 by September 2022.

Outlook Therapeutics reported its fiscal second quarter results, highlighting the submission of the BLA for ONS-5010 and ongoing pre-commercial launch activities. The company reported a net loss of $19.7 million, or $0.09 per share, and had cash and cash equivalents of $58.4 million as of March 31, 2022.

Outlook Therapeutics reported a net loss attributable to common stockholders of $14.5 million, or $0.08 per basic and diluted share, for the fiscal first quarter ended December 31, 2021. The company's cash and cash equivalents were $70.2 million at the end of the quarter.

Outlook Therapeutics reported a net loss attributable to common stockholders of $53.2 million for the fiscal year ended September 30, 2021. The company had cash and cash equivalents of $14.5 million at the end of the fiscal year and completed a $57.5 million gross proceeds equity offering subsequent to the fiscal year end.

Outlook Therapeutics reported a net loss attributable to common stockholders of $12.2 million, or $0.07 per basic and diluted share, and had cash and cash equivalents of $19.7 million as of June 30, 2021. The company plans to submit a BLA for ONS-5010 in the first calendar quarter of 2022.

Outlook Therapeutics reported a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $17.5 million, or $0.36 per basic and diluted share for the same period last year. The company's cash and cash equivalents were $37.2 million as of March 31, 2021.

Outlook Therapeutics reported a net loss attributable to common stockholders of $14.5 million, or $0.12 per basic and diluted share, and had cash and cash equivalents of $5.6 million at the end of the quarter.

Outlook Therapeutics reported a net loss attributable to common stockholders of $48.9 million, or $0.67 per basic and diluted share, compared to a net loss attributable to common stockholders of $36.0 million for the prior fiscal year.

Outlook Therapeutics reported a net loss attributable to common stockholders of $3.0 million, or $0.03 per basic and diluted share, for the fiscal third quarter ended June 30, 2020. The company had cash and cash equivalents of $24.0 million at June 30, 2020.

Outlook Therapeutics reported its financial results for the second quarter of fiscal year 2020, with a net loss attributable to common stockholders of $17.5 million, or $0.36 per share. The company highlighted progress in its ONS-5010 development program and the upcoming data readout for the NORSE 1 clinical trial.

Outlook Therapeutics reported a net loss attributable to common stockholders of $18.5 million, or $0.62 per basic and diluted share, for the fiscal first quarter ended December 31, 2019. The company is advancing towards a new BLA submission to the FDA for ONS-5010 in 2021, with a potential commercial launch in 2022.