Outlook Therapeutics Q2 Net Loss Narrows; Expects FDA Decision For LYTENAVA In May 2026

(RTTNews) - Outlook Therapeutics, Inc. (OTLK), a biopharmaceutical company, announced financial results for the second quarter of fiscal year 2026, ended March 31, 2026, and provided a corporate update.

Company Profile

Outlook Therapeutics is developing and commercialising ONS-5010/LYTENAVA (bevacizumab-vikg), an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, including wet age-related macular degeneration (wet AMD). In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational. LYTENAVA has received European Commission and MHRA Marketing Authorisation for the treatment of wet AMD.

Second Quarter Results

For the second quarter, net loss attributable to common stockholders narrowed to $4.45 million, or $0.05 per share, from $46.35 million, or $1.50 per basic and diluted share in the prior year.

Adjusted net loss increased to $14.07 million, or $0.16 per basic and diluted share, compared to $12.45 million, or $0.40 per basic and diluted share in the year ago.

Net revenue amounted to $0.13 million in the second quarter. Unit sales of LYTENAVA in Europe for the second fiscal quarter of 2026 were approximately 10% lower than the quarter ended December 31, 2025, although the company stated that trends improved early in the current quarter.

In addition, the firm noted that it has taken steps to reduce costs in Europe to improve margins in future quarters.

As of March 31, 2026, Outlook Therapeutics had cash and cash equivalents of $7.7 million, which does not include the net proceeds of the April 2026 registered direct offering.

Near-Term Milestones

ONS-5010/LYTENAVA (bevacizumab-vikg) is under investigation in the United States, and the firm continues to advance its regulatory efforts.

In December 2025, the firm received a Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) from the U.S. Food and Drug Administration (FDA) for the treatment of neovascular age-related macular degeneration. The CRL cited a deficiency related to "substantial evidence of effectiveness" and recommended additional confirmatory evidence.

In April 2026, the company held its formal dispute resolution meeting with the FDA and remains engaged in the process, awaiting the FDA's formal decision in May 2026.

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