Protara Therapeutics (NasdaqGM:TARA) Update / briefing February 24, 2026 08:00 AM ET Company ParticipantsCarla Beckham - Lead Medical Director and Head of Clinical DevelopmentJacqueline Zummo - Co-Founder and Chief R&D OfficerJesse Shefferman - Co-founder, Director and CEOJustine O'Malley - SVP of Investor Relations and Corporate AffairsNeal Shore - Medical DirectorSoumit Roy - Managing Director and Head of Healthcare ResearchStacy Ku - Biotechnology Equity ResearchConference Call ParticipantsAndres Maldona ...

Protara Therapeutics (NasdaqGM:TARA) Update / briefing February 24, 2026 08:00 AM ET Company ParticipantsCarla Beckham - Lead Medical Director and Head of Clinical DevelopmentJacqueline Zummo - Chief R&D OfficerJesse Shefferman - Co-Founder, Director, and CEOJustine O'Malley - SVP of Investor Relations and Corporate AffairsNeal Shore - Medical DirectorSwayam Sheth - Equity Research AssociateConference Call ParticipantsAndres Maldonado - Senior Biotechnology Equity Research AnalystCharles Zhu - Managing Dire ...

Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events Company expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in 2H 2026 Company to host conference call and webcast tomorrow at 8:00 a.m. ET NEW YORK, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated interim results ...

Core Insights - Protara Therapeutics, Inc. is set to present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) at the ASCO Genitourinary Cancers Symposium in February 2026 [1][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with TARA-002 as its lead candidate for NMIBC and lymphatic malformations [8] - TARA-002 is an investigational cell therapy derived from genetically distinct group A Streptococcus pyogenes, which has been granted Rare Pediatric Disease Designation by the FDA [5][8] Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is an open-label Phase 2 study assessing TARA-002 in NMIBC patients, specifically those who are BCG-Unresponsive or BCG-Naïve [3] - Approximately 25 patients will be evaluated for updated safety and efficacy data in the upcoming presentation [2] - The trial includes an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course [3] Presentation Information - The poster presentation titled "ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer" will take place on February 27, 2026 [4] - Another poster titled "Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2" will also be presented on the same day [5] Mechanism of Action - TARA-002 acts as a first-in-class TLR2/NOD2 agonist, activating both innate and adaptive immune pathways within the bladder wall, leading to a pro-inflammatory response and direct tumor cell death [6] Market Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases diagnosed annually [8]

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Core Viewpoint - Protara Therapeutics is a clinical stage biotechnology company focused on developing transformative therapies for rare cancer diseases, with a strong emphasis on oncology and rare diseases [2]. Oncology Focus - The company has two late-stage development programs targeting non-muscle invasive bladder cancer, specifically in BCG-Unresponsive and BCG-Naïve patients [2][4]. - The ADVANCED-2 study is a significant registrational study for BCG-Unresponsive patients with carcinoma in situ, with expectations to complete enrollment before the end of 2026 [4]. Rare Disease Programs - Protara is developing two products in clinical development for rare diseases: - IV Choline Chloride, a phospholipid substrate replacement therapy for patients on parenteral support, currently in Phase III with a pharmacokinetic-based endpoint [3]. - TARA-002, targeting lymphatic malformations for macrocystic and mixed cystic lesions [3]. Company Ambition - Despite its size, Protara demonstrates significant ambition through its diverse portfolio of late-stage development programs in both oncology and rare diseases [4].

Protara Therapeutics Conference Call Summary Company Overview - **Company**: Protara Therapeutics (NasdaqGM:TARA) - **Industry**: Biotechnology, focusing on rare diseases and oncology - **Key Areas**: Non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations Core Points and Arguments Oncology Focus - Protara is developing therapies for non-muscle invasive bladder cancer, with two late-stage programs targeting BCG unresponsive and BCG naive patients [3][4] - The ADVANCED-2 study is a significant registrational study for BCG-unresponsive patients, with expected enrollment completion by the end of 2026 [4] - A randomized controlled trial (RCT) for BCG-naive patients has been approved by the FDA, marking a first in the NMIBC setting [4][11] Lymphatic Malformations Program - Protara's TAR 002 program targets macrocystic lymphatic malformations, showing a 100% clinical success rate at the eight-week evaluation point [7][14] - The company received breakthrough therapy designation and fast-track designation from the FDA, indicating a significant unmet need in this area [15][16] Market Opportunities - In NMIBC, 80% of patients are treated in community settings, where safety and tolerability are critical [9] - Protara's 002 therapy is positioned as a best-in-class option due to its safety profile and ease of administration [10] - The market opportunity for lymphatic malformations is estimated at around 1,000 patients annually in the U.S., with a focus on macrocystic cases [17][20] Clinical Data and Expectations - Upcoming data release in February for the ADVANCED-2 study is anticipated to show a complete response (CR) rate similar to previous findings of 72.4% at six months and 50% at twelve months [6][27] - The company aims to demonstrate that BCG-experienced and BCG-refractory patients respond similarly to TAR 002 [8] Competitive Landscape - Protara aims to position its therapies as alternatives to BCG, particularly for patients who cannot receive BCG [25] - The company is focused on generating level one evidence through its RCT, which will enhance its standing with payers and in treatment guidelines [12][13] Future Developments - Protara expects to begin receiving FDA approvals for its programs starting in 2027, with a robust pipeline of late-stage developments [22] - The IV Choline Chloride program is also in phase three, targeting a patient population of approximately 40,000 in the U.S. [21] Additional Important Content - The company emphasizes the importance of patient advocacy in raising awareness about new treatment options for lymphatic malformations [19] - Protara's leadership reflects on the journey of developing their portfolio, highlighting the progress made since going public in 2020 [34][35]

Core Insights - Protara Therapeutics is on track to report interim results from approximately 25 six-month evaluable patients in the ADVANCED-2 trial in Q1 2026, focusing on BCG-Unresponsive patients [1][5] - The company has received Breakthrough Therapy and Fast Track designations for TARA-002 in lymphatic malformations (LMs), with a regulatory update expected in the first half of 2026 [1][4] - The first patient has been dosed in the THRIVE-3 registrational trial of IV Choline Chloride, with interim results anticipated in the second half of 2026 [1][7] - Protara completed a public offering of approximately $86 million, extending its cash runway into 2028 [1][8] Protara's Pipeline and Progress - The CEO emphasized the company's commitment to delivering transformative therapies for cancer and rare diseases, highlighting the promising clinical data for TARA-002 in non-muscle invasive bladder cancer (NMIBC) [2] - TARA-002 has shown meaningful and durable activity in BCG-Naïve NMIBC patients, with plans to provide an interim update on the registrational BCG-Unresponsive trial later this quarter [2][5] - Positive results from the Phase 2 STARBORN-1 trial of TARA-002 in LMs have led to FDA designations, with a regulatory update on the path to registration expected in H1 2026 [2][4] Clinical Trials and Manufacturing - Protara is evaluating subcutaneous dosing combined with intravesical dosing for TARA-002 in NMIBC patients, as well as exploring combination treatments [5] - TARA-002 has been selected for the FDA's CMC Development and Readiness Pilot Program, aimed at facilitating manufacturing development for therapies with compressed clinical timelines [6] Financial Update - The recent public offering of approximately $86 million is expected to support Protara's operations and extend its financial runway into 2028 [8]

Core Insights - Protara Therapeutics, Inc. has initiated patient dosing in its Phase 3 THRIVE-3 clinical trial for intravenous Choline Chloride, aimed at patients on long-term parenteral support [1][2] - The company believes that IV Choline Chloride could be the first FDA-approved IV choline therapy for patients dependent on parenteral support, addressing a significant unmet medical need [2][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with its lead candidate being TARA-002 for non-muscle invasive bladder cancer and lymphatic malformations [5][6] - The company is also developing IV Choline Chloride as a phospholipid substrate replacement therapy for patients unable to meet their choline needs through oral or enteral nutrition [4][5] Clinical Trial Details - The THRIVE-3 trial is a seamless Phase 2b/3 study designed to evaluate the efficacy and safety of low and high doses of IV Choline Chloride in patients receiving long-term parenteral support [2][3] - Approximately 105 additional patients will be enrolled in a 24-week Phase 3 double-blinded, randomized, placebo-controlled trial, following an 8-week Phase 2b trial involving 24 patients [2][3] Medical Context - Choline deficiency affects 78% of patients on parenteral support, leading to serious health issues, yet there are currently no approved IV choline products available [2][4] - IV Choline Chloride has been granted Fast Track and Orphan Drug Designation by the FDA, highlighting its potential significance in treating choline deficiency in this patient population [4][5]

Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [3] - The company's lead candidate is TARA-002, an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - Protara is conducting an ongoing Phase 2 trial for TARA-002 in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin treatment, as well as a Phase 2 trial in pediatric patients with LMs [3] Upcoming Events - Management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 pm PT in San Francisco [1] - A live webcast of the presentation will be available on the company's website, with an archive accessible for a limited time after the event [2] Additional Information - Protara is also developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]