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Investor Relations14 Oct 2025
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Protara Therapeutics (TARA) investor relations material
Protara Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary9 Sep, 2025
Key clinical data and regulatory updates
Largest lymphatic malformation dataset from a 27-center study of 550+ patients will support FDA registration, with interim data expected before year-end.
NMIBC program is accelerating enrollment in a single-arm, open-label study for BCG-unresponsive CIS patients, with interim data on at least 25 patients to be published in February.
TARA-002 shows a distinct mechanism from BCG, upregulating key oncolytic cytokines and downregulating IL-8, which is linked to recurrence.
BCG-naive proof-of-concept study shows 70+% complete response at 6 months and 40+% at 12 months; regulatory pathway discussions ongoing.
No treatment-related grade 3 adverse events reported; most side effects are mild and related to administration or flu-like symptoms.
Product differentiation and market opportunity
TARA-002 offers easy administration, no special handling, and rapid patient discharge, differentiating it from BCG and other therapies.
Approximately 35% of BCG-eligible patients in the US do not receive BCG, representing 10,000–12,000 patients annually who may benefit from alternatives.
Ongoing FDA dialogue to enable a randomized controlled study comparing TARA-002 to chemotherapy in BCG-ineligible patients.
Safety and efficacy profile positions TARA-002 favorably among both approved and investigational NMIBC products.
Pipeline expansion and future plans
IV Choline Chloride pivotal study is enrolling, with primary endpoint of elevated serum choline at 8 weeks; interim data expected mid-2026.
Liver function and other metabolic endpoints will be evaluated due to the role of phosphatidylcholine in organ health.
TARA-002 is standard of care for macrocystic lymphatic malformations in Japan; interim data from US study expected before year-end.
University of Iowa study shows 62% complete response and 84% clinically meaningful response in macrocystic patients; current study aims to replicate these results.
Expansion into other maxillofacial cystic indications could address up to 12.5 million US patients.
What is the regulatory path for BCG-alternative?
What is the strategy for 12.5M maxillofacial cysts?
How does TARA-002's profile drive adoption?
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Next Protara Therapeutics earnings date
Q3 20253 Nov, 2025
Next Protara Therapeutics earnings date
Q3 20253 Nov, 2025
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Frequently asked questions
Protara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing transformative therapies for cancer and rare diseases. Their lead program, TARA-002, is an investigational cell therapy aimed at treating lymphatic malformations, based on the broad immunopotentiator OK-432. Additionally, Protara is developing intravenous choline chloride, a phospholipid substrate replacement therapy for the treatment of intestinal failure-associated liver disease. The company is headquartered in NYC, and its shares are listed on the Nasdaq.
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