Aura Biosciences (AURA) investor relations material

Leadership and strategic vision

• New CEO attracted by the unique opportunity and underappreciated market for bel-sar in early choroidal melanoma, citing a compelling value proposition and lack of innovation in the space.

• Focus for the next 12-24 months is on completing the CoMpass study, BLA preparation, and potential commercial launch.

• Recent financing provides a cash runway into the back half of 2028, supporting ongoing and future programs.

Clinical development and data highlights

• Phase II study of bel-sar via suprachoroidal injection showed 80% tumor control, 90% visual acuity preservation, and a favorable safety profile at 12 months.

• Phase III CoMpass study is a 3-arm, 100-patient trial with primary endpoint of time to tumor progression at 15 months; secondary endpoint includes visual acuity failure.

• Study design and endpoints aligned with FDA via SPA, providing clarity for BLA filing; enrollment is complete and data readout expected in the second half of 2027.

• Phase III is over 99% powered to detect an 80% response rate, mirroring phase II results.

Market opportunity and competitive landscape

• Early-stage choroidal melanoma incidence is about 8,000 patients per year in the US and EU5, with potential for growth as new treatments emerge.

• Bel-sar is the only treatment in development for early choroidal melanoma; current options are watch and wait or radiotherapy, both with significant drawbacks.

• Introduction of bel-sar could shift diagnostic and treatment paradigms, expanding the treatable population.