Slide 1: ADVANCED-2 Trial Interim Results December 2024
ADVANCED - 2 TRIAL INTERIM RESULTS December 2024
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 . Protara may, in some cases, use terms such as “predicts,” “believes,” “po
Slide 3: Promising NMIBC therapy and de-risked rare disease programs
Promising NMIBC therapy C de - risked rare disease programs 3 TARA - 002 in NMIBC • Dosing underway in Phase 2 STARBORN - 1 trial • TARA - 002 predecessor is standard of care in Japan • U.S. FDA granted Rare Pediatric Disease Designation – PRV eligible • Positive interim results from ADVANCED - 2 tr
Slide 4: Unique product characteristics anticipated to drive significant adoption
Anticipated low burden on physicians s patients Favorable safety s tolerability Encouraging interim ADAVNCED - 2 data • No additional administration procedures or safety protocols required • Fast administration typically performed by nurse • Dedicated to ensuring access with minimal burden • To date
Slide 5: Activates Th1 Immune Cascade: broad immunopotentiation
Activates Th1 Immune Cascade (1)(2)(3) BROAD IMMUNOPOTENTIATION = POTENTIAL FOR DURABLE RESPONSE Mechanism similar to BCG, unique to other agents in development 1. Fujimoto T., et al. J Immunol. 1997: 5619. | 2. Ryoma Y, et al. Anticancer Res. 2004; 3295 - 3298. | 3. Zhao H, et al. Microbiol. Immuno
Slide 6: Demonstrated 72% six-month CRR and 70% CRR at any time across BCG exposures
TARA - 002 demonstrated 72% six - month CRR and 70% CRR at any time across BCG exposures Abbreviations: BCG = Bacillus Calmette - Guérin; CR = complete response; CIS = carcinoma in situ; Dx = diagnosis; NMIBC = non - muscle invasive bladder cancer Notes: At the time of data cutoff, 20 subjects were
Slide 7: Demonstrated 100% durability with reinduction salvage rate of 80%
TARA - 002 demonstrated 100% durability from 3 months to 6 months with a reinduction salvage rate of 80% 1 © 2021 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 7 Abbreviations: BCG = Bacillus Calmette - Guérin; CR = complete response; CIS = carcinoma in situ NOTES: At the tim
Slide 8: Favorable safety and tolerability in interim analysis of ADVANCED-2
8 TARA - 002 demonstrated favorable safety and tolerability in interim analysis of ADVANCED - 2 trial Data cut - off date: 19 November 2024 AEs reflect urinary tract instrumentation effects and known safety profile of an immune - potentiating drug Abbreviations: AE = adverse event; NMIBC = non - mus
Slide 9: Differentiated profile in NMIBC with encouraging interim data
9 UNIQUE MOA • Only broad immunopotentiator in the industry pipeline • Non - clinical data points to encouraging durability • No overlapping toxicities with other novel therapeutic in NMIBC POTENTIAL EASE ON PROVIDERS s PATIENTS • To date, no Grade 2 or greater treatment - related adverse events • S
Slide 10: QCA
QCA © 2024 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute 10
Slide 11: Appendix
APPENDIX
Slide 12: ADVANCED-2 trial design
TARA - 002 in NMIBC: ADVANCED - 2 trial design 12 © 2024 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute Protara Confidential Information Data cut - off date: 19 November 2024 RE - induction (if eligible*) Maintenance (months 6 - 18) Month 3 Month 6 Month 18 Month 60 Maintenanc
Slide 13: ADVANCED-2 demographics and disease characteristics
ADVANCED - 2 demographics and disease characteristics 13 © 2024 Protara Therapeutics. All Rights Reserved – Do Not Copy or Distribute Data cut - off date: 19 November 2024 N = 24 N = 24 Prior BCG Status, n (%) Age (years) 17 (71) BCG Naïve 71 (10.9) Mean (SD) 2 (8) BCG Exposed 71 Median 5 (21) BCG U