Aura Biosciences (AURA) Status Update summary

Key clinical data and program updates

• Final phase II data for bel-sar in choroidal melanoma showed 80% tumor control and 90% vision preservation at 12 months, with a highly favorable safety profile and minimal adverse events.

• Responders experienced a reduction in tumor growth rate from 0.351 mm/yr to 0.011 mm/yr (p < 0.0001).

• The phase III COMPASS trial is enrolling globally, targeting small, high-risk tumors, with endpoints mirroring phase II and a primary focus on time to tumor progression.

• Bel-sar is administered via suprachoroidal injection and laser activation, offering an office-based, non-surgical alternative to radiotherapy.

• The market opportunity spans multiple ocular oncology indications, with potential expansion into other solid tumors and a strong cash position funding operations into the second half of 2026.

Safety and tolerability

• No treatment-related serious adverse events or dose-limiting toxicities were reported.

• Mild ocular adverse events included anterior chamber inflammation (18%) and cell (9%), resolving without sequelae.

• Most inflammation events were self-limited, resolving in a median of 6 days, with topical steroids used when needed.

• No treatment-related posterior inflammation events were observed.

• Bel-sar's safety and vision preservation profile may shift treatment paradigms, encouraging earlier detection and intervention.

Clinical and patient management implications

• Bel-sar offers a new early intervention option, potentially replacing watchful waiting and delaying or avoiding radiotherapy for small, high-risk tumors.

• Patients who progress after bel-sar remain eligible for radiotherapy, with no increased risk of complications, and the possibility of multiple bel-sar treatments exists.

• The inclusion of indeterminate lesions in the trial design aligns with real-world clinical practice, where diagnosis is often clinical rather than histopathological.

• Long-term follow-up in phase III will provide data on durability of tumor control and potential impact on metastasis rates.

• 80% of patients were at high risk for vision loss due to tumor proximity to the fovea or optic disc.