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Earnings

Aura Third-Quarter Net Loss Widens to $32.1 Million

Aura's third-quarter 2026 net loss widened to $32.1 million as research and development expenses rose to $24.7 million. All 108 Phase 3 participants have finished bel-sar treatment, and cash and cash equivalents and marketable securities totaled $297.2 million at September 30.

Aura Biosciences, Inc. (AURA) reported a net loss of $32.1 million for the third quarter ended September 30, 2026, compared with $26.1 million a year earlier, as research and development expenses increased to $24.7 million from $22.2 million. The company said all 108 participants in its Phase 3 CoMpass trial of belzupacap sarotalocan (bel-sar) for early choroidal melanoma have completed their treatment regimen and are in a 24-month follow-up observation period, with topline data from the 15-month primary endpoint still on track for the second half of 2027.

The clinical-stage biotechnology company also completed an organizational restructuring in the third quarter to align resources behind its ocular oncology portfolio, incurring about $4.5 million of charges.

Enrollment had been finished in the second quarter, when the company said the 108-patient count exceeded the enrollment target. The trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration, which the company said represents alignment on trial design and planned analyses to support a potential Biologics License Application. If successful, Aura said bel-sar would be the first approved front-line vision-preserving therapy for early choroidal melanoma, a setting with no FDA-approved drug therapies.

Net loss for the three months ended September 30, 2026 was $32.1 million, or $0.29 a share, compared with $26.1 million, or $0.40 a share, a year earlier. Weighted average shares outstanding rose to 111.1 million from 65.9 million.

Research and development expenses increased to $24.7 million from $22.2 million, which the company attributed primarily to ongoing clinical and contract research organization costs associated with the progression of the global Phase 3 CoMpass trial. General and administrative expenses rose to $10.3 million from $5.7 million, including $2.8 million and $1.7 million of stock-based compensation, respectively. The company said the increase was primarily driven by restructuring charges recognized during the third quarter.

Those charges comprised employee termination benefits, including severance, continuation of health care benefits, and outplacement services, as well as incremental stock-based compensation from accelerated vesting of certain awards. The restructuring plan was completed in the third quarter. In the second quarter, Aura had already streamlined its operating plan and organizational structure to focus on ocular oncology, including a reduction in force of approximately 20% of the workforce, and had minimized resource allocation toward the non-muscle invasive bladder cancer program after interim Phase 1b/2 data.

During the quarter, Aura established a new supply relationship with an industry-leading contract development and manufacturing organization with commercial experience in viral vector-based medicinal products. The company and the CDMO are establishing manufacturing capacity designated for bel-sar development and commercial supply production. Chief Operating Officer Susan Abu-Absi said designated capacity is intended to provide long-term control over production scheduling.

Aura continues to advance bel-sar in metastases to the choroid and cancers of the ocular surface in ongoing early clinical trials. In the first quarter of 2027, the company expects to provide an update on both programs, including details on disease burden, trial design, and timelines to future data read-outs.

As of September 30, 2026, cash and cash equivalents and marketable securities totaled $297.2 million. The company believes those resources are sufficient to fund operations into the first half of 2029. That runway had already been communicated after the second-quarter restructuring.

Chief Executive Officer Natalie Holles said the team is focused on ensuring excellence in all elements of the bel-sar program as it advances toward topline pivotal data in the second half of next year and positions bel-sar as the first potential vision-preserving front-line therapy for early choroidal melanoma. Aura will host an early choroidal melanoma investor and analyst virtual event on December 8, 2026.

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