Protara Therapeutics (TARA) investor relations material

Study Design and Patient Population

• ADVANCED-2 is an ongoing phase II, open-label trial evaluating TARA-002 in NMIBC patients, including BCG-naive and BCG-unresponsive cohorts.

• BCG-naive cohort included 31 patients; 29 were evaluable for efficacy as of November 7, 2025.

• The study population included both CIS-only and CIS with papillary disease, with a 58%/42% split.

• BCG-naive cohort had a mean age of 70.4 years, 80.6% male, and 93.5% White; 90.3% had never been exposed to BCG.

• Some patients had prior BCG exposure outside the 24-month window, reflecting real-world diversity.

Efficacy and Durability Results

• TARA-002 achieved a 72% complete response (CR) rate at any time, 69% at 6 months, and 50% at 12 months in BCG-naive NMIBC patients.

• Among initial responders, 88% maintained response at 6 months and 100% at 12 months.

• Reinduction therapy converted 80% of initial non-responders to CR at 6 months; all maintained CR at 12 months.

• Efficacy was robust across both CIS-only and CIS with papillary subgroups.

• TARA-002's efficacy compares favorably to intravesical chemotherapy, which has ~40% six-month CR and lower durability.

Safety and Tolerability

• TARA-002 demonstrated a favorable safety profile, with most adverse events being grade 1 and transient.

• No grade 3 or higher treatment-related adverse events and no discontinuations due to AEs.

• Most common adverse events were dysuria (13%), fatigue (13%), and hematuria (6%).

• No treatment-related serious adverse events were reported.

• Simplicity of administration and lack of biohazard precautions distinguish TARA-002 from BCG.