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 in phase II had a reduction in tumor growth rate from 0.351 mm/yr to 0.011 mm/yr (p < 0.0001).

• The phase III COMPASS study is enrolling globally, targeting small, early-stage melanomas with strict entry criteria and a primary endpoint of time to tumor progression.

• The patient population for phase III closely mirrors the phase II cohort, focusing on small tumors with documented growth, and includes indeterminate lesions.

• The company is well-funded, with operations supported into the second half of 2026 and multiple upcoming clinical data readouts expected.

Clinical impact and treatment paradigm

• Current standard radiotherapy leads to predictable and often severe vision loss, with legal blindness in up to 87% of patients, requiring long-term anti-VEGF injections for some.

• Bel-sar offers a new option for early intervention, potentially replacing watchful waiting and providing an alternative for patients at high risk of vision loss.

• The ability to preserve vision while controlling tumor growth is seen as a major advance, especially for tumors near critical visual structures.

• The treatment is expected to shift clinical practice by enabling earlier intervention and increasing the number of patients identified and treated at an earlier stage.

• Long-term data will be important to determine durability of tumor control and the potential for repeat treatments or subsequent radiotherapy if needed.

Safety and technical considerations

• No treatment-related serious adverse events or dose-limiting toxicities were reported; mild, self-limited inflammation was the main adverse event.

• Mild ocular adverse events included anterior chamber inflammation (18%) and cell (9%), resolving without sequelae, typically in a median of 6 days.

• Suprachoroidal injection is technically straightforward for retina specialists, and the laser activation uses familiar equipment.

• In contrast, radiotherapy requires hospital-based surgery, general anesthesia, and carries risks of pain, infection, and long-term vision loss.

• The phase III study design includes close monitoring and allows for timely intervention with standard care if progression occurs.