Aura Biosciences Reports $86.9 Million Net Loss for Fiscal Year 2024

Aura Biosciences, Inc., a clinical-stage biotechnology company, reported a net loss of $86.9 million for the fiscal year ending December 31, 2024, compared to a net loss of $76.4 million in the previous year. The company's accumulated deficit now stands at $374.2 million. The increase in losses is attributed primarily to rising research and development expenses, which grew to $73.3 million from $65.2 million, driven by ongoing clinical trials and manufacturing costs associated with its lead product candidate, belzupacap sarotalocan (bel-sar). General and administrative expenses also rose to $22.8 million, reflecting increased personnel costs and corporate expenses.

Aura's lead candidate, bel-sar, is currently in late-stage clinical development for the treatment of primary choroidal melanoma and is also being evaluated for other ocular oncology indications and bladder cancer. The company is conducting a global Phase 3 trial, known as the CoMpass trial, which aims to assess the efficacy of bel-sar as a vision-sparing therapy. In previous Phase 2 studies, bel-sar demonstrated an 80% tumor control rate and a 90% visual acuity preservation rate among high-risk patients. The company plans to expand its clinical development efforts to include additional indications, such as metastases to the choroid and cancers of the ocular surface.

As of December 31, 2024, Aura had cash and cash equivalents totaling $151.1 million, which the company believes will fund its operations into the second half of 2026. However, the company anticipates needing substantial additional funding to support ongoing research and development activities, particularly as it advances bel-sar through clinical trials and seeks regulatory approvals. The company has raised approximately $419.9 million since its inception, primarily through equity offerings, including a recent follow-on offering that generated $99 million in gross proceeds.

Aura's workforce consists of 106 full-time employees, with a significant portion engaged in research and development. The company is focused on building its operational capabilities to support the commercialization of bel-sar, should it receive regulatory approval. However, the company faces various risks, including reliance on third-party manufacturers for production, potential delays in clinical trials, and the need to navigate complex regulatory environments. The company has not yet generated any revenue from product sales and does not expect to do so until it secures marketing approval for bel-sar or any future product candidates.

Looking ahead, Aura remains optimistic about the potential of bel-sar to transform treatment paradigms in ocular oncology and bladder cancer. The company is committed to advancing its clinical programs and expanding its product pipeline, although it acknowledges the inherent uncertainties and challenges associated with drug development. The success of its business strategy will depend on achieving key milestones, including regulatory approvals and market acceptance of its product candidates.