Adverum Biotechnologies Reports $130.9 Million Net Loss for 2024, License Revenue Declines

Adverum Biotechnologies, Inc. reported a net loss of $130.9 million for the year ended December 31, 2024, compared to a restated net loss of $122.1 million in 2023. License revenue decreased significantly to $1 million in 2024 from $3.6 million in 2023. Operating expenses increased by $7.6 million to $140.2 million in 2024, primarily due to a rise in general and administrative expenses, partially offset by a decrease in research and development expenses. The company's cash, cash equivalents, and short-term investments totaled $125.7 million as of December 31, 2024.

The company's 2023 financial statements were restated to correct non-cash errors in lease accounting related to a North Carolina property. These errors affected the reported amounts of non-cash assets and liabilities, and non-cash general and administrative expenses. The restatement resulted in a decrease in the reported operating loss for 2023. In March 2025, the company initiated ARTEMIS, the first of two Phase 3 clinical trials for its lead product candidate, ixoberogene soroparvovec, intended for wet age-related macular degeneration. The second Phase 3 trial, AQUARIUS, is planned for the second half of 2025.

Ixoberogene soroparvovec utilizes a proprietary AAV.7m8 capsid and is designed for a single intravitreal injection. Top-line 52-week results from the LUNA Phase 2 trial showed that both doses maintained visual and anatomic outcomes, with favorable reductions in anti-VEGF injections. The company also highlighted strong patient preference for ixoberogene soroparvovec over prior anti-VEGF therapies. Adverum is developing an early-stage pipeline of gene therapy programs targeting other ocular diseases. As of December 31, 2024, the company employed approximately 155 full-time employees.

The company's manufacturing process is based on the Baculovirus/Sf9 production system and is conducted through collaborations with external vendors. Adverum maintains control over key aspects of the manufacturing process, including scalable process development and GMP quality controls. The company faces competition from larger pharmaceutical and biotechnology companies developing treatments for similar indications. Adverum's strategy focuses on targeting large patient populations with single-injection gene therapies and pursuing indications with well-defined regulatory pathways.

Adverum's 10-K filing notes substantial doubt about its ability to continue as a going concern due to its significant operating losses and insufficient cash resources to fund operations for at least 12 months from the filing date. The company plans to raise additional funding through various means, including equity or debt financings and strategic partnerships. The filing also details various risks related to its financial position, product development, manufacturing, intellectual property, commercialization, and regulatory compliance. The company's outlook is contingent upon successful fundraising and the advancement of its clinical trials.