Protara Therapeutics Conference Call Summary Company Overview - **Company**: Protara Therapeutics - **Ticker**: TARA - **Industry**: Biotechnology Key Assets and Development Programs TARA-002 - **Indications**: - Non-muscle invasive bladder cancer (NMIBC) - Lymphatic malformations - **Development Stage**: Late-stage development for both indications [3][4] Mechanism of Action - TARA-002 is a genetically distinct strain of inactivated Streptococcus pyogenes, engineered to retain its immune-stimulating properties [4] - It has been used in Japan for decades as a standard of care for lymphatic malformations and adjunctively with chemotherapy for various cancers [5] Clinical Trials and Data - **ADVANCED-2 Study**: - Focuses on BCG-unresponsive NMIBC patients - Reported a 68% complete response rate at 6 months from 22 patients [9] - Preliminary 12-month complete response rate of 33% from 15 evaluable patients [9] - **ADVANCED-3 Study**: - Aims to utilize TARA-002 in the frontline setting as an alternative to BCG, targeting a significant population due to BCG shortages [6][16] - **STARBORN-1 Study**: - Focused on macrocystic and mixed cystic lymphatic malformations, with ongoing patient enrollment and upcoming FDA engagement for a registrational path [41] Market Opportunity - **Unmet Need**: - Approximately 35% of BCG-eligible patients do not receive BCG due to shortages or intolerance, translating to an annual population of 11,000 to 15,000 patients [25][26] - Potentially addressing tens of thousands of patients annually, including those exposed to BCG [27] - **Competitive Landscape**: - TARA-002 is positioned as a viable alternative in the NMIBC setting, with a focus on ease of use and reliability compared to existing treatments [32] Regulatory Insights - The FDA has indicated that a head-to-head trial against BCG is not necessary, which may facilitate a smoother path to approval [19] Other Programs IV Choline Chloride - **Target Population**: Approximately 35,000 patients in the U.S. on long-term chronic TPN [56] - **Clinical Need**: High prevalence of choline deficiency and liver dysfunction in patients on parenteral nutrition [56] - **Intellectual Property**: Orange Book listed product claim patent extending to 2041, providing exclusivity [62] Financial Considerations - The company is optimistic about pricing strategies based on established benchmarks in the NMIBC setting, allowing flexibility in both NMIBC and lymphatic malformations markets [46] Conclusion - Protara Therapeutics is actively advancing its clinical programs, particularly TARA-002, which addresses significant unmet needs in oncology. The company is well-positioned to capture market share in both NMIBC and lymphatic malformations, with a favorable regulatory outlook and a strong pipeline of assets.

PresentationOperator Hello, and welcome to the Protara Therapeutics ASCO GU Update Call. [Operator Instructions] As a reminder, this conference call is being recorded. If you have any objections, please disconnect at this time. With that, I would now like to turn the call over to Justine O'Malley, Senior Vice President, Investor Relations and Corporate Affairs. ...

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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]