Outlook Therapeutics Reports $17.4M Net Income Turnaround, Prepares for EU and UK Launch of ONS-5010/LYTENAVA

Outlook Therapeutics, Inc. reported a net income of $17.4 million for the three months ending December 31, 2024, a significant turnaround from a net loss of $11.2 million during the same period in 2023. This change was primarily driven by a $40.3 million gain from the change in fair value of warrant liabilities, compared to a modest gain of $53,342 in the previous year. Total operating expenses increased to $21.6 million, up from $10.3 million in the prior year, largely due to heightened research and development costs associated with the ongoing clinical trials for its lead product candidate, ONS-5010/LYTENAVA.

The company’s research and development expenses surged to $9.7 million, compared to $4.5 million in the prior year, reflecting increased activity related to the NORSE EIGHT clinical trial. General and administrative expenses also rose to $11.9 million from $5.8 million, influenced by prelaunch expenses in Europe and severance costs following the resignation of the former CEO. The increase in expenses contributed to a loss from operations of $21.6 million, compared to a loss of $10.3 million in the same quarter of the previous year.

In terms of financial position, Outlook Therapeutics reported total assets of $17.0 million as of December 31, 2024, down from $28.8 million at the end of the previous fiscal year. The company’s cash and cash equivalents decreased significantly to $5.7 million from $14.9 million. Current liabilities increased to $48.2 million, primarily due to the unsecured convertible promissory note, which rose to $30.7 million from $29.4 million. The accumulated deficit also narrowed to $525.9 million from $543.3 million, indicating a slight improvement in the overall financial health of the company.

Strategically, Outlook Therapeutics has made significant progress with its product candidate, ONS-5010/LYTENAVA, which received marketing authorization from the European Commission and the UK Medicines and Healthcare products Regulatory Agency for the treatment of wet age-related macular degeneration. The company is preparing for a potential launch in the EU and UK in the second quarter of 2025, with plans to submit a Biologics License Application (BLA) to the FDA in early 2025. However, the company has acknowledged substantial doubt about its ability to continue as a going concern, citing the need for additional financing to support operations and product development.

Looking ahead, Outlook Therapeutics is actively exploring various funding strategies, including potential licensing agreements, equity offerings, and collaborations with other pharmaceutical companies. The company has also entered into a Warrant Inducement Transaction, generating approximately $15.7 million in net proceeds, and plans to issue a new convertible promissory note to address existing obligations. Despite the challenges, the company remains focused on advancing its clinical programs and preparing for commercial operations, contingent upon successful regulatory approvals.