Aura Biosciences (AURA) investor relations material

Strategic focus and milestones

• Bel-sar is being developed first for early choroidal melanoma; pivotal CoMpass enrollment of 108 patients completed in May 2026, with top-line efficacy data expected in H2 2027.

• The NMIBC program will be completed but deprioritized as resources concentrate on ocular oncology; preliminary NMIBC data reported over the summer were described as encouraging.

• The longer-term ocular oncology strategy includes choroidal metastases and ocular surface tumors; a fuller update on these programs is planned for Q1 2027.

Clinical profile and trial design

• Bel-sar is a locally administered therapy with tumor-cell-selective activity activated by ophthalmic laser; phase II therapeutic-dose patients had 80% tumor control and 90% vision preservation.

• Phase II safety was described as favorable: most AEs were grade 1, with no treatment-related SAEs or discontinuations; 90% of patients preserved vision.

• CoMpass’s primary efficacy analysis is at 15 months, assessing tumor control; patients will be followed for 24 months for durability, vision preservation, and safety.

• FDA-agreed documented tumor growth at enrollment enriches for a more consistent population; the study was described as over 99% powered at 100 subjects to detect a difference in line with phase II results.

• Phase III inclusion criteria and assessments largely match phase II; the primary assessment extends from 12 to 15 months.

Unmet need and market opportunity

• Current choices include observation, radiotherapy that can stop growth but often leads to irreversible vision loss, or enucleation; larger tumors carry greater metastatic risk.

• Management views the potential population as spanning early tumors historically classified as indeterminate lesions or small choroidal melanomas, with treatment potentially used earlier than radiotherapy today.

• An updated early choroidal melanoma epidemiology review is planned for Dec. 8, 2026, with market research and clinician discussion of evolving disease classification.

• About 90% of ocular oncologists in the U.S. and Europe are involved in the clinical program; the focused specialist network is expected to support a commercial launch.

• Treatment is designed for office administration: two injections 30 minutes apart, followed by laser treatment four to six hours later, with limited practice changes expected.