Protara Therapeutics (TARA) Corporate presentation summary

Transformative investigational therapies in oncology and rare disease

• TARA-002 shows positive interim data in non-muscle invasive bladder cancer (NMIBC), with FDA support for registrational trial design and selection for the FDA's CMC Development & Readiness Pilot Program.

• IV Choline Chloride addresses a high unmet need in parenteral support patients, with 78% choline deficiency and no approved IV formulations; granted FDA Orphan Drug and Fast Track designations.

• TARA-002 in lymphatic malformations (LMs) achieved 80% clinical success in treated patients and 100% in those completing 8-week assessment, with multiple FDA designations for rare pediatric disease.

Robust late-stage pipeline and clinical milestones

• Multiple late-stage trials ongoing or planned for TARA-002 in NMIBC, including BCG-naïve and BCG-unresponsive cohorts, with interim and full enrollment milestones in 2026.

• STARBORN-1 trial for LMs and THRIVE-3 for IV Choline are advancing, with regulatory feedback and enrollment milestones expected in 2026.

• $134M in cash and equivalents as of September 2025, with a cash runway into 2028 after a $86M public offering.

TARA-002 in NMIBC: Efficacy, safety, and differentiation

• TARA-002 activates both innate and adaptive immunity via TLR2/NOD2, offering a novel mechanism beyond BCG.

• Demonstrated 100% complete response (CR) at 6 months and 66.7% at 12 months in BCG-unresponsive patients; 69% CR at 6 months and 50% at 12 months in BCG-naïve patients.

• Favorable safety profile with mostly mild to moderate adverse events and no grade 4/5 events in BCG-naïve and BCG-unresponsive cohorts.

• Designed for ease of use, with simple preparation and administration, fitting community urology workflows.

• Distinct cytokine signature and robust single-agent activity, with competitive CR rates and encouraging durability.