Protara Therapeutics, Inc. · NASDAQ:TARA
Protara Therapeutics — Investor Presentation (August 2026)
33 slides from Protara Therapeutics's investor presentation, August 2026
Slide 1: Corporate Presentation
Corporate Presentation August 2026
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,” “pot
Slide 3: Transformative Investigational Therapies in Oncology and Rare Disease
Transformative Investigational Therapies in Oncology and Rare Disease ONCOLOGY RARE PEDIATRIC TARA-002 in Non-Muscle TARA-002 in Lymphatic Malformations Invasive Bladder Cancer • Pediatric program for indication with no currently • Positive interim data in BCG- approved therapies available in the US
Slide 4: Diversified Late-Stage Pipeline
Diversified Late-Stage Pipeline Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Expected Status ONCOLOGY Indicates potential clinical programs yet to be initiated CIS + Ta/T1 NMIBC ADVANCED-2 (Cohort A) Fully enrolled BCG-Naïve TARA-002 ADV-2 CIS + Ta/T1 NMIBC Full enrollment ADVANCED-2 (Cohort B) B
Slide 5: Multiple Near-Term Milestones Anticipated
Multiple Near-Term Milestones Anticipated NMIBC IV Choline LMs ADVANCED-2 BCG-UN enrollment complete (4Q’26) Initiate ADVANCED-3 BCG-Naïve trial being redesigned Systemic administration pre-clinical data (2H’26) ADVANCED-2 BCG-UN interim analysis (Q1’26) STARBORN-1 enrollment complete (4Q’26) LMs Re
Slide 6: TARA-002: Non-Muscle Invasive Bladder Cancer (NMIBC)
TARA-002 Non-Muscle Invasive Bladder Cancer (NMIBC)
Slide 7: TARA-002: A Unique TLR2/NOD2 Agonist Derived From Streptococcus pyogenes
TARA-002: A Unique TLR2/NOD2 Agonist Derived From Streptococcus pyogenes That Brings a New Immunologic Mechanism to NMIBC Beyond BCG TARA-002 ignites both innate and adaptive immunity through dual TLR2/NOD2 activation, driving potent local anti-tumor / cystic responses via fully inactivated bacteria
Slide 8: TARA-002 Monotherapy Demonstrates 68% CR at 6 Months in BCG-Unresponsive Participants
TARA-002 Monotherapy Demonstrates 68% CR at 6 Months with Durable Response Among BCG-Unresponsive Participants High-grade CR rate at any time (%) 100 65.7% 23 of 35 80 60 40 20 0 N=35 Landmark High-grade CR rate (%) Month 6 68.2 (15 of 22) Month 12 33.3 (5 of 15) Reinduction Salvage 61.5 (8 of 13) D
Slide 9: TARA-002 Monotherapy Demonstrates 67% CR at 6 Months in BCG-Naïve Participants
TARA-002 Monotherapy Demonstrates 67% CR at 6 Months with Durable Response Among BCG-Naïve Participants High-grade CR rate at any time (%) 100 72.4% 21 of 29 80 60 40 20 0 N = 29 Landmark High-grade CR rate (%) Abbreviations: CR = complete response Data cutoff: April 05, 2026 High-grade CR is based
Slide 10: BCG-Naïve: Favorable Safety and Tolerability Profile with No Grade 3 or Greater TRAEs
BCG-Naïve: TARA-002 in NMIBC Demonstrated a Favorable Safety and Tolerability Profile with No Grade 3 or Greater TRAEs N = 31 Any Grade Grade 1 Grade 2 Grade 3 Grade 4/5 TRAEs, n (%) 8 (26) 8 (26) 1 (3) 0 0 TRAEs ≥5%, n (%) Dysuria 4 (13) 4 (13) 0 0 0 Fatigue 4 (13) 3 (10) 1 (3) 0 0 Hematuria 2 (6)
Slide 11: Addressing Multiple HGHR NMIBC Patient Populations
Addressing Multiple HGHR NMIBC Patient Populations US Prevalent Bladder Cancer ~744,0001 CIS +/- Ta/T1 Papillary Ta / T1 US Incident Bladder Cancer BCG- Across BCG- ~85,000/year1 BCG-UN BCG-Naive Exposed Exposures Non-Muscle ADVANCED-2 ADVANCED-3* Invasive ~65,000/year2 ADVANCED-3* HR NMIBC ~25,000/
Slide 12: The Majority Of NMIBC Patients are Treated by Community Urologists
The Majority Of NMIBC Patients are Treated by Community Urologists Most NMIBC patients are treated in the community – Estimated NMIBC Patient Distribution by Site of Care Urologists prefer to retain their patients (TDG Prior Research BCG Utilization Data Set, 2023-2024, Estimated % of NMIBC Patients
Slide 13: NMIBC: Safety & Ease Of Use Are Important to Adoption
NMIBC: Safety & Ease Of Use Are Important to Adoption Bloomberg surveyed 51 urologists on their views of key adoption factors of approved and next-generation therapies NMIBC products launched in the last 2+ years Recently launched or expected to launch shortly 1 Requirements to give BCG 1 1 3 Patien
Slide 14: TARA-002 Is Designed For Best-in-Class Ease of Use in NMIBC
TARA-002 Is Designed For Best-in-Class Ease of Use in NMIBC TARA-002 has reduced burden for patients and physicians Anktiva + BCG-TICE Adstiladrin Inlexzo Cretostimogene TARA-002 Risk of infection for patient Vial thaw introduces Requires insertion every three Complex process with unclear No vial th
Slide 15: TARA-002 Target Product Profile in NMIBC
TARA-002 Target Product Profile Sits at the Intersection that NMIBC Patients and Urologists Prioritize • Mild, self-limited local AEs • Robust single agent activity • Predictable, well- Safety & Efficacy and • Competitive CR rates characterized safety profile Tolerability Durability • Encouraging du
Slide 16: TARA-002: Lymphatic Malformations (LMs)
TARA-002 Lymphatic Malformations (LMs)
Slide 17: LMs Represent a Significant Pediatric Rare Disease Opportunity
LMs Represent a Significant Pediatric Rare Disease Opportunity with No Currently Approved Therapies Lymphatic Malformations (LMs) are rare, non-malignant, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect to or drain into the venous system1 LMs are
Slide 18: Incident Patients Diagnosed in Community and Referred to Vascular Anomaly Centers
1,400-1,800 Incident Patients are Typically Diagnosed in the Community Setting and Most are Referred to Vascular Anomaly Centers (VACs) Community prefers surgery or referral and COEs/VACs prefer sclerotherapy Community ENT, Dermatologist, Pediatrician, Surgeon Referral Sclerotherapy Surgery Complica
Slide 19: TARA-002 Demonstrated Clinical Success in 83% of Participants Completing Treatment
TARA-002 Demonstrated Clinical Success in 83% of Participants that Completed Treatment and 100% of Evaluable Participants 100% CLINICAL SUCCESS RATE 83% CLINICAL SUCCESS RATE AT 8-WEEKS POST-TREATMENT AT 8-WEEKS POST-TREATMENT* IN EVALUABLE PARTICIPANTS^ 83% 100% 16% 20% 67% 80% 17% N = 12 N = 10 Wi
Slide 20: TARA-002 Demonstrated 100% Durable Response at 32-Weeks
TARA-002 Demonstrated 100% Durable Response at 32-Weeks 100% DURABLE RESPONSE AT 32-WEEKS POST-TREATMENT IN EVALUABLE PARTICIPANTS^ 100% 29% 71% N=7 Complete Response Substantial Response • 7 participants have reached the 32-weeks post-treatment assessment and remain disease free ^Excludes ongoing p
Slide 21: TARA-002 Has Demonstrated Meaningful Results in STARBORN-1
TARA-002 Has Demonstrated Meaningful Results in LMs Patients Treated in the STARBORN-1 Study Medical photography: Baseline and 8-week post-treatment results for three participants treated with TARA-002 in the STARBORN-1 trial BEFORE BEFORE AFTER BEFORE AFTER AFTER Baseline 1,739mL macrocystic LM rec
Slide 22: TARA-002 Has a Favorable and Well-Tolerated Safety Profile
TARA-002 Has a Favorable and Well-Tolerated Safety Profile • Most AEs were mild to moderate • No serious TEAEs or AESIs have occurred to date Number of Participants, N = 16 Any Grade Grade 1 Grade 2 Grade 3 Grade 4/5 TEAEs, n (%) 11 (69) 11 (69) 9 (56) 1 (6) 0 (0) Related TEAEs, n (%) 10 (63) 10 (63
Slide 23: TARA-002 in LMs is a Late-Stage Opportunity with Significant Unmet Need
TARA-002 in LMs is a Late-Stage Opportunity with Significant Unmet Need TARA-002 IN LMS • FDA Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track Designations • Intend to submit BLA in 2H’2027 with results of STARBORN-1 pivotal trial; interim results demonstrate promising effica
Slide 24: IV Choline Chloride
IV Choline Chloride Phospholipid substrate replacement therapy for patients dependent on parenteral support (PS)
Slide 25: IV Choline Chloride is a Late-Stage Opportunity with High Unmet Medical Need
IV Choline Chloride is a Late-Stage Opportunity with High Unmet Medical Need Has the potential to become the first approved IV choline formulation for PS patients HIGH UNMET NEED WITH LARGE MARKET POSITIVE CLINICAL DATA AND ALREADY OPPORTUNITY INCLUDED IN MEDICAL GUIDELINES • ~30K patients on PS lon
Slide 26: Independent Phase 2 Study: IV Choline Restores Choline Levels and Improves Steatosis
Independent Phase 2 Study Demonstrates that Treatment with IV Choline Rapidly Restores Choline Levels and Improves Steatosis PLASMA FREE CHOLINE LEVELS: CLINICALLY MEANINGFUL ALL PATIENTS1 IMPROVEMENT IN STEATOSIS1 3 Choline supplementation was discontinued at week 24. 3 Placebo *CT converted to MRI
Slide 27: Large Market Opportunity for IV Choline in Parenteral Support
Large Market Opportunity for IV Choline to Address a Clear, Guideline Supported Unmet Medical Need in PS IV Choline Commercial Analogs US Patients requiring PS >110,000 per year Patients on long term PS at home ~30,000 ASPEN (US) and ESPEN (EU) guidelines IV Choline Market Research – Intent to treat
Slide 28: Appendix
Appendix 6 Mbrora RA THERAPEUTICS
Slide 29: TARA-002 Demonstrates Differentiated Profile to BCG
TARA-002 Demonstrates Differentiated Profile to BCG TARA-002 treatment promotes differential pro-inflammatory TH1-type cytokines than BCG in co-culture1 Cytokines BCG TARA-002 TARA-002 Potent Immune Activation IFN-γ --- + with a Distinct Cytokine Signature • Distinct cytokine profile marked by stron
Slide 30: TARA-002 in NMIBC: ADVANCED-2 Clinical Trial Design
TARA-002 in NMIBC: ADVANCED-2 Clinical Trial Design Primary endpoint of high-grade complete response (CR) at any time up to 6 months; Key secondary endpoint of 12-month DOR DAY 1 MONTH 3 MONTH 6 MONTH 24 MONTH 60 REGISTRATIONAL DESIGN*: BCG-Unresponsive (CIS ± Ta/T1) Induction (N=75-100) CR, Mainten
Slide 31: Pivotal Phase 2 STARBORN-1 Trial
Pivotal Phase 2 STARBORN-1 Trial STARBORN-1 is a Single Arm, Open-Label Safety and Efficacy Study of TARA-002 in Pediatric Patients with Macrocystic & Mixed cystic LMs (N=29) • Patients receive up to four injections of TARA-002 spaced approximately six weeks apart • DMC review with FDA for each safe
Slide 32: STARBORN-1 Interim Results: Evaluable Participants Across Cyst Types
STARBORN-1 Interim Results: Evaluable Participants Across Cyst Types STRONG RESPONSE ACROSS CYST TYPES IN EVALUABLE POPULATION: MACROCYSTIC LMs, MIXED CYSTIC LMs, RANULAS 100% 100% 100% Macrocystic LMs (N = 7) Mixed-cystic LMs (N = 1) Ranula (N = 2) Complete Response Substantial Response • Clinical
Slide 33: THRIVE-3 Pivotal Trial with PK and Liver Function Endpoints
Pivotal Trial with PK and Liver Function Endpoints 1g/day WEEK 8 THRIVE-3 is a seamless Phase 2b/3 trial with dose confirmation followed by Open-Label Dose Selection Choline Chloride double-blinded, randomized, placebo-controlled trial to assess the safety and 1:1:1 Randomization efficacy of IV Chol
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