Aura Biosciences (AURA) Status Update summary

Program and Platform Overview

• Bel-sar is a novel, dual-mechanism therapy aiming to redefine bladder cancer treatment, with a platform showing promise across multiple solid tumors and already in phase III for ocular oncology, supported by positive phase II data in choroidal melanoma.

• The bladder cancer program targets both non-muscle invasive (NMIBC) and muscle-invasive (MIBC) disease, with positive phase I data in NMIBC and plans for expansion into other urologic and solid tumors.

• Bel-sar is designed for focal, office-based administration, avoiding general anesthesia and aligning with standard urology practices.

Vision, Leadership, and Unmet Need

• Aura aims to innovate cancer care by curing patients and preserving organ function, led by experts in urologic oncology and experienced executives.

• Bladder cancer is the 9th most common cancer globally, with over 600,000 cases annually, high recurrence rates, and suboptimal current treatments leading to multiple surgeries, significant side effects, and high costs.

• 84% of patients do not complete a full BCG treatment course, partly due to shortages.

Mechanism of Action and Clinical Advantages

• Bel-sar offers targeted cytotoxicity and long-term anti-tumor immune memory, aiming to preserve bladder function and reduce recurrence and treatment burden.

• The approach enables both immune-ablative (standalone) and neoadjuvant (pre-surgical) strategies, potentially replacing or reducing the need for TURBT and adjuvant therapies.

• Multiplex immunofluorescence showed early activation of both innate and adaptive immunity, including NK, CD4+, and CD8+ T cells.