On November 9, 2026 Aura Biosciences, Inc. (NASDAQ: AURA) ("Aura" or the "Company") a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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"During the third quarter, we continued to execute against our focused ocular oncology strategy and build the operational capabilities needed for our next stage of development," said Natalie Holles, Chief Executive Officer of Aura Biosciences. "With all treatment visits completed in the CoMpass trial, our team is focused on ensuring excellence in all elements of the bel-sar program as we advance toward topline pivotal data in the second half of next year and position bel-sar as the first potential vision-preserving front-line therapy for early choroidal melanoma."

Recent Business Highlights

Phase 3 CoMpass Trial in Early Choroidal Melanoma

Enrollment is complete with 108 participants in the Phase 3 CoMpass trial of belzupacap sarotalocan (bel-sar) for the treatment of early choroidal melanoma, the most common primary tumor of the eye which carries an approximately 50% risk of advancing to metastatic disease. As of the third quarter of 2026, all participants have completed their treatment regimen and are in the 24-month follow-up observation period. The trial is on track to deliver topline data from the 15-month primary endpoint in the second half of 2027.

The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPA represents alignment with the FDA on the trial design and planned analyses to support a potential Biologics License Application (BLA) of bel-sar. If successful, bel-sar would be the first approved front-line vision-preserving therapy for patients with early choroidal melanoma, providing a meaningful new treatment option where no FDA-approved drug therapies currently exist.

Additional Ocular Oncology Programs

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

Operational Updates

During the quarter, Aura established a new supply relationship with an industry-leading contract development and manufacturing organization (CDMO) with extensive commercial experience in the manufacture of viral vector-based medicinal products. In a key element of the relationship, Aura and its CDMO partner are establishing manufacturing capacity which will be designated for bel-sar development and commercial supply production.

"We are very pleased to enter this new CDMO relationship, which we believe positions bel-sar for regulatory and commercial success as we advance toward topline data and completion of the CoMpass study," said Susan Abu-Absi, Ph.D., Chief Operating Officer of Aura Biosciences. "Designated capacity is intended to provide us with long-term control over our production scheduling, and we look forward to working with our new partner to advance this important element of the bel-sar program."

Upcoming Events

Aura will host an early choroidal melanoma investor and analyst virtual event on Tuesday, December 8, 2026, from 7:30-9:00 a.m. ET. Members of Aura’s management team will be joined by key opinion leader, Dr. Arun Singh, Director of the Department of Ophthalmic Oncology in the Cole Eye Institute of the Cleveland Clinic. The event will address the current treatment paradigm and unmet need, and an updated analysis of the epidemiology of early choroidal melanoma. To register for the virtual event, click here.

Aura also announced that Natalie Holles, Chief Executive Officer and President, will participate in the following upcoming investor conferences in the fourth quarter of 2026:

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Stifel 2026 Healthcare Conference on Tuesday, November 10, 2026.
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Fireside chat at 2:40 p.m. ET
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9th Annual Evercore Healthcare Conference on Tuesday, December 1, 2026.
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Fireside chat at 2:10 p.m. ET

The live webcast of the events will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company’s website at View Source, where a replay of the webcasts will be archived for 90 days following the presentation date.

Third Quarter 2026 Financial Results

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As of September 30, 2026, Aura had cash and cash equivalents and marketable securities totaling $297.2 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first half of 2029.

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Research and development expenses increased to $24.7 million for the three months ended September 30, 2026 from $22.2 million for the three months ended September 30, 2025, primarily due to ongoing clinical and contract research organization (CRO) costs associated with the progression of the global Phase 3 CoMpass trial of bel-sar in early choroidal melanoma.

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General and administrative expenses increased to $10.3 million for the three months ended September 30, 2026 from $5.7 million for the three months ended September 30, 2025. General and administrative expenses include $2.8 million and $1.7 million of stock-based compensation for the three months ended September 30, 2026 and 2025, respectively. The increase was primarily driven by restructuring charges recognized in accordance with the Company’s organizational restructuring during the third quarter of 2026.

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Net loss for the three months ended September 30, 2026 was $32.1 million compared to $26.1 million for the three months ended September 30, 2025.

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In connection with the Company’s organizational restructuring to align resources behind its ocular oncology portfolio, the Company incurred restructuring charges of approximately $4.5 million, comprised of employee termination benefits which include severance, continuation of health care benefits, and outplacement services as well as incremental stock-based compensation expense resulting from the acceleration of vesting of certain stock-based awards. The restructuring plan was completed in the third quarter of 2026.

(Press release, Aura Biosciences, NOV 9, 2026, View Source [SID1234674464])