Protara Therapeutics (TARA) 2025 Conference Transcript

Protara Therapeutics (TARA) Conference Call Summary Company Overview - Protara Therapeutics is a development-stage company focused on oncology and rare diseases, with two main franchises: oncology (specifically bladder cancer) and rare diseases [2][3] Oncology Segment TARA-002 Program - TARA-002 is a genetically distinct strain of Streptococcus pyogenes, currently in registrational studies for non-muscle invasive bladder cancer (NMIBC) [2] - The program aims to leverage established biological mechanisms and evolving science to accelerate development and commercialization [2] - Previous data releases showed a 100% complete response rate in a small cohort of BCG-unresponsive carcinoma in situ (CIS) patients, with 80% at six months and over 60% at 12 months [5][6] - Upcoming data release will include 18-month data for both BCG-unresponsive and BCG-naive patients [7][8] Competitive Landscape - Competitive response rates are discussed, with a threshold of 50% complete response at six months to be part of the conversation, and 75% or higher considered a "category killer" [9][10] - Protara aims to differentiate TARA-002 by its ease of administration, similar to BCG, and a favorable safety profile [29][30] Enrollment and Regulatory Pathway - Enrollment is proceeding as expected, with a focus on the right patient population [31] - The company is actively adding international sites to enhance enrollment, particularly in the BCG-unresponsive cohort [31] - Discussions with the FDA regarding the regulatory pathway for BCG-naive patients are ongoing, with updates expected by the end of the year [44] Rare Disease Segment IV Choline Chloride Program - The Thrive 3 trial is a phase 2B3 seamless design study, currently facing enrollment challenges in the U.S. due to competition for hospital beds [46][47] - European sites are expected to enroll significantly more patients, with one site in France having 500 patients on parenteral support [49][50] - Initial data from the Thrive 3 trial is anticipated by the summer of 2026 [51] Key Priorities - The primary focus for the upcoming year is on patient enrollment across both oncology and rare disease programs [52][54] Additional Insights - The management team has extensive experience in biotech and drug development, which informs their strategic approach [3] - Protara's strategy includes a focus on manufacturing capabilities and cost of goods sold, which allows for competitive pricing and distribution flexibility [30]