Aura Biosciences (AURA) Status Update summary

Program and Clinical Development Overview

• Bel-sar is a novel therapy for bladder cancer, combining targeted cytotoxicity and immune activation, supporting both immune-ablative and neoadjuvant approaches.

• The platform is being developed for multiple cancers, with ongoing trials in ocular oncology and pre-IND work in other solid tumors.

• Phase 1b/2 trials are underway to optimize dosing and regimens for intermediate- and high-risk NMIBC, with both immune-ablative and neoadjuvant arms.

Clinical Data and Safety Profile

• Phase 1 data in NMIBC showed no serious adverse events or dose-limiting toxicities; only grade 1 drug-related events in less than 10% of patients.

• Four of five intermediate-risk and one of five high-risk NMIBC patients achieved complete response with light activation.

• Immune cell infiltration and formation of tertiary lymphoid structures were observed in both target and non-target lesions, supporting a urothelial field effect.

Mechanism of Action and Differentiation

• Bel-sar's dual mechanism combines rapid tumor cell destruction with long-term anti-tumor immune memory, aiming to reduce recurrence and preserve bladder function.

• Immune activation is evidenced by T and B cell infiltration, NK, CD4+, and CD8+ T cell activation, and formation of tertiary lymphoid structures.

• The approach is distinct from BCG and intravesical chemotherapy, offering more targeted, durable, and patient-friendly therapy.