TARA News & Events

Protara Therapeutics "announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in patients with high-risk Non-Muscle Invasive Bladder Cancer with carcinoma in situ or CIS (+/- Ta/T1) who are Bacillus Calmette-Guerin -Unresponsive or BCG-Naive. These results will be featured on Friday, February 27, 2026 during poster sessions at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient with no Grade 3 or greater TRAEs and no related serious adverse events as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most common TRAEs were dysuria, bladder spasm, fatigue and micturition urgency. Most bladder irritations resolved shortly after administration or within a few hours to a few days. Protara expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in the second half of 2026. Enrollment is complete in the BCG-Naive cohort of the ADVANCED-2 trial with 31 patients, and the Company remains on track to initiate the ADVANCED-3 registrational trial in BCG-Naive patients in the second half of 2026."

Protara Therapeutics highlighted recent updates and anticipated 2026 milestones. Milestones include: On track to report interim results from approximately 25 six-month evaluable BCG-Unresponsive patients in ADVANCED-2 trial in Q1 2026; Received Breakthrough Therapy and Fast Track designations for TARA-002 in LMs; regulatory update expected in 1H 2026; Dosed first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on long-term parenteral support and expect to report interim results in 2H 2026; Recently completed approximately $86 million public offering extending cash runway into 2028

Protara Therapeutics, announced that patient dosing is now underway in its Phase 3 registrational THRIVE-3 clinical trial evaluating intravenous Choline Chloride in patients receiving long-term parenteral support. IV Choline Chloride, the Company's investigational phospholipid substrate replacement therapy, was previously granted Fast Track designation by the U.S. Food and Drug Administration.