Aura Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents plus marketable securities totaled $297.2 million as of September 30, 2026, providing a runway into the first half of 2029.
• Research and development expenses increased to $24.7 million for the three months ended September 30, 2026, from $22.2 million in the same period in 2025, driven by clinical and CRO costs for the Phase 3 CoMpass trial.
• General and administrative expenses rose to $10.3 million for the three months ended September 30, 2026, compared to $5.7 million in the prior year period, primarily due to $4.5 million in restructuring charges and increased stock-based compensation ($2.8 million vs. $1.7 million).
• 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.
• Total operating expenses for the nine months ended September 30, 2026, were $118.0 million, up from $85.6 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $111.4 million, compared to $80.6 million in the prior year period.
• Interest income, including amortization and accretion, was $3.0 million for the three months ended September 30, 2026, compared to $1.8 million in the prior year period.
• Total assets increased to $321.6 million as of September 30, 2026, from $169.4 million as of December 31, 2025, largely due to an increase in marketable securities to $255.6 million from $84.7 million.
• Total stockholders' equity grew to $287.4 million as of September 30, 2026, from $136.9 million as of December 31, 2025.
• Weighted average common stock outstanding was 111.1 million for the three months ended September 30, 2026, compared to 65.9 million in the prior year period.

Guidance and Future Outlook:

• The Phase 3 CoMpass trial is on track to deliver topline data for the 15-month primary endpoint in the second half of 2027.
• All 108 participants in the Phase 3 CoMpass trial have completed treatment visits and are currently in the 24-month follow-up observation period.
• Aura expects to provide updates in the first quarter of 2027 regarding ongoing early clinical trials for bel-sar in metastases to the choroid and cancers of the ocular surface, including details on disease burden, trial design, and timelines.
• The company believes its current cash resources are sufficient to fund operations into the first half of 2029.

Business Segments and Product Lines:

• The primary focus remains on bel-sar (belzupacap sarotalocan), a first-in-class therapy for early choroidal melanoma, which is the most common primary tumor of the eye with an approximately 50% risk of advancing to metastatic disease.
• The Phase 3 CoMpass trial is conducted under a Special Protocol Assessment (SPA) agreement with the FDA to support a potential Biologics License Application (BLA).
• Aura has established a new supply relationship with an industry-leading CDMO with designated manufacturing capacity for bel-sar development and commercial supply production.
• Development is ongoing for bel-sar in metastases to the choroid and cancers of the ocular surface through early clinical trials.

Market and Competitive Landscape:

• If approved, bel-sar would be the first FDA-approved front-line vision-preserving therapy for patients with early choroidal melanoma, addressing a market where no FDA-approved drug therapies currently exist.
• The company aims to position bel-sar as a transformative therapy that arrests tumor growth while preserving vision and quality of life.

Risks and Challenges:

• Forward-looking statements highlight risks including uncertainties inherent in clinical trials, the availability and timing of data, and the potential for trial results to differ from expectations.
• Risks include the possibility that governmental authorities may disagree with clinical trial designs despite SPA agreements, the risk of not receiving regulatory approvals, and the risk that cash resources may be insufficient to fund operating expenses.
• The company relies on third-party manufacturers and faces risks related to the initiation, enrollment, conduct, or completion of ongoing and planned clinical trials.

Management Commentary and Tone:

• CEO Natalie Holles stated the team is focused on executing a focused ocular oncology strategy and ensuring excellence in the bel-sar program to advance toward pivotal data in the second half of 2027.
• COO Susan Abu-Absi expressed pleasure in the new CDMO relationship, noting it positions bel-sar for regulatory and commercial success by providing long-term control over production scheduling.

Other Key Points:

• The company incurred approximately $4.5 million in restructuring charges during the third quarter of 2026 to align resources behind its ocular oncology portfolio, covering severance, health care benefits, outplacement services, and accelerated stock-based compensation.
• An early choroidal melanoma investor and analyst virtual event is scheduled for December 8, 2026, featuring Dr. Arun Singh from the Cleveland Clinic.
• CEO Natalie Holles will participate in the Stifel 2026 Healthcare Conference on November 10, 2026, and the 9th Annual Evercore Healthcare Conference on December 1, 2026.
• The number of issued and outstanding shares increased to 103.95 million as of September 30, 2026, from 63.59 million as of December 31, 2025.
• Treasury stock of 6.92 million shares was held at September 30, 2026, with no treasury shares held at December 31, 2025.