Aura Biosciences (AURA) investor relations material

Strategic focus and clinical development

• Leadership prioritized ocular oncology, shifting resources from bladder cancer to focus on bel-sar for early choroidal melanoma, with the bladder program being completed for current participants only.

• The phase III CoMpass trial is fully enrolled, targeting early choroidal melanoma with top-line data expected in the second half of 2027 and a 24-month endpoint in 2028.

• The trial design includes three arms (80 mcg bel-sar, 40 mcg bel-sar, and sham), with primary efficacy measured by tumor progression or cessation of growth and a key secondary endpoint of vision preservation.

• Regulatory alignment was achieved with the FDA via Special Protocol Assessment and with the EMA, increasing the probability of approval if endpoints are met.

• Long-term follow-up will track safety, tumor control, and vision preservation for up to five years post-treatment.

Clinical impact and market opportunity

• Bel-sar offers a new paradigm by providing tumor control comparable to radiotherapy but with 90% vision preservation, addressing a major unmet need.

• The market for early choroidal melanoma is estimated at 8,000 patients annually across the US and major European markets, with potential for expansion as earlier lesions are treated.

• Adoption is expected to be facilitated by a focused commercial effort targeting approximately 100 ocular oncologists in the US and Europe, leveraging existing infrastructure.

• The main hurdle to adoption is regulatory approval, with reimbursement and infrastructure considered manageable.

• Bel-sar's mechanism and delivery system create high barriers to entry, with exclusivity expected through at least 2040.

Pipeline expansion and future catalysts

• Resources have been redirected to choroidal metastases and ocular surface cancer programs, with updates planned for Q1 next year.

• Non-clinical and early clinical data support bel-sar's potential in other ocular cancers, including choroidal metastases from breast and lung cancer.

• Ongoing studies will assess immune activation and tumor shrinkage in ocular surface cancers, informing future development.

• The company aims to establish a steady cadence of clinical catalysts over the next three years, culminating in a potential launch in 2027.