Core Insights - Protara Therapeutics reported significant progress in 2025, particularly with positive interim results from the ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) [2][5] - The company plans to initiate the THRIVE-3 Phase 3 clinical trial for IV Choline Chloride in Q3 2025, targeting patients on parenteral support [4][5] - Protara's financial results for Q1 2025 show a net loss of $11.9 million, with cash reserves expected to support operations into 2027 [14][24] Recent Progress and Highlights - TARA-002 demonstrated a complete response (CR) rate of 100% in BCG-Unresponsive patients and 76% in BCG-Naïve patients during the ADVANCED-2 trial [6] - The company expects to announce interim results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 [5][6] - Leadership team strengthened with key appointments, including Dr. Leonardo Viana Nicacio as Chief Medical Officer [9] Financial Overview - As of March 31, 2025, Protara had cash, cash equivalents, and investments totaling $158 million, sufficient to fund operations into 2027 [5][14] - Research and development expenses increased to $9.1 million in Q1 2025 from $7.7 million in the prior year, primarily due to clinical trial activities [14][24] - General and administrative expenses rose to $5.0 million in Q1 2025 from $4.1 million in the prior year [14][24] Product Development - TARA-002 is being evaluated for NMIBC and lymphatic malformations (LMs), with ongoing trials expected to yield interim updates in the second half of 2025 [8][11] - IV Choline Chloride is positioned as a potential first FDA-approved IV choline formulation for patients on parenteral nutrition [16] - The company continues to explore combination treatments and dosing strategies for TARA-002 in NMIBC patients [6][12]

TARA-002 Product Characteristics - TARA-002 is a lyophilized, inactivated Group A Streptococcus pyogenes [8] - TARA-002 is an investigational, genetically distinct strain of Streptococcus pyogenes that is inactivated while retaining its immune-stimulating properties [10] - TARA-002 activates Th1 Immune Cascade [12] Clinical Trial Results in BCG-Unresponsive Patients - TARA-002 monotherapy demonstrates a 100% complete response rate at any time in BCG-unresponsive participants [14] - Specifically, 5 out of 5 (100%) BCG-unresponsive patients with CIS only achieved a high-grade complete response at any time [15] - At Month 6, 5 out of 5 (100%) BCG-unresponsive patients with CIS only achieved a high-grade complete response [15] - At Month 12, 2 out of 3 (66.7%) BCG-unresponsive patients with CIS only achieved a high-grade complete response [15] Clinical Trial Results in BCG-Naïve Patients - TARA-002 monotherapy demonstrates a 76.2% complete response rate at any time in BCG-naïve participants [22, 23] - Specifically, 10 out of 11 (90.9%) BCG-naïve patients with CIS only achieved a high-grade complete response at any time [23] - At Month 6, 5 out of 6 (83.3%) BCG-naïve patients with CIS only achieved a high-grade complete response [23] - At Month 12, 3 out of 5 (60.0%) BCG-naïve patients with CIS only achieved a high-grade complete response [23] Safety Profile - Across both BCG-unresponsive and BCG-naïve patients (N=43), 74% experienced any grade of treatment-emergent adverse events (TEAEs) [25] - 30% of participants experienced related TEAEs [25] - No Grade 4/5 treatment-related adverse events were observed [7, 25]

Core Insights - Protara Therapeutics, Inc. has granted inducement non-qualified stock options and restricted stock units (RSUs) to six newly-hired employees as part of its 2020 Inducement Plan [1][2][3] Employee Compensation - Shane Williams, the new Vice President, Head of Human Resources and Chief People Officer, received 41,000 stock option awards and 20,500 RSU awards with an exercise price of $4.32 per share on April 25, 2025 [2] - An aggregate of 59,100 stock option awards and 29,550 RSU awards were granted to five new employees on May 1, 2025, with an exercise price of $3.46 per share [3] Vesting Schedule - All option awards vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting monthly thereafter [4] - RSU awards vest over three years, with 33 1/3% vesting on each of the three consecutive anniversaries of the grant date [4] Company Overview - Protara is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases, including its lead candidate TARA-002 for non-muscle invasive bladder cancer and lymphatic malformations [5] - The company is conducting ongoing Phase 2 trials for TARA-002 in patients with carcinoma in situ and pediatric patients with lymphatic malformations [5] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [5]

Summary of Protara Therapeutics (TARA) Update / Briefing April 28, 2025 Company Overview - **Company**: Protara Therapeutics - **Focus**: Development of TARA-two, an investigational treatment for non-muscle invasive bladder cancer (NMIBC) Key Industry Insights - **Clinical Trial**: Ongoing Phase II ADVANCE-two clinical trial of TARA-two in NMIBC patients - **Treatment Landscape**: TARA-two is positioned as a competitive option in the evolving NMIBC treatment landscape, particularly for BCG unresponsive patients Core Findings and Arguments 1. **Positive Interim Results**: TARA-two demonstrated a complete response (CR) rate of 100% at any time and 100% at six months in the BCG unresponsive cohort, with rates of 80% at nine months and 67% at twelve months [12][15] 2. **Durable Responses**: The treatment shows durable responses at twelve months in both BCG unresponsive and naive cohorts, with 76% CR at any time in the naive cohort [15] 3. **Safety Profile**: TARA-two exhibited a favorable safety profile, with most adverse events being grade one and transient, and no patients discontinued due to adverse events [16] 4. **Mechanism of Action**: TARA-two activates a broader immunologic profile compared to other therapies, potentially leading to durable antitumor responses [9][14] 5. **Regulatory Engagement**: The company is in discussions with the FDA regarding the design of registrational studies for both BCG unresponsive and naive patient populations [15][81] Additional Important Insights 1. **Patient Enrollment**: The company has seen an increase in trial enrollment due to site expansion efforts, with 17 patients currently enrolled [12][28] 2. **Future Milestones**: Protara anticipates additional data updates and milestones throughout the year, including a preplanned analysis of 25 BCG unresponsive patients by the end of 2025 [19][29] 3. **Combination Therapy Potential**: The company is exploring systemic priming and combination therapies to enhance treatment efficacy and patient quality of life [45][47] 4. **Market Positioning**: TARA-two is viewed as a potential best-in-class treatment for NMIBC, with characteristics that drive adoption among healthcare providers [32][33] Conclusion - Protara Therapeutics is making significant strides in the development of TARA-two for NMIBC, with promising interim results and a strong safety profile. The company is well-positioned to capitalize on upcoming milestones and regulatory discussions, potentially transforming the treatment landscape for patients with NMIBC.

Core Insights - Protara Therapeutics, Inc. announced updated results from its Phase 2 ADVANCED-2 trial for TARA-002, a cell-based therapy for high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients, which will be presented at the American Urological Association 2025 Annual Meeting [1][2] Interim Results - The BCG-Unresponsive cohort included five patients, all evaluable at six and nine months, with three evaluable at 12 months as of April 16, 2025 [3] - The BCG-Naïve cohort included 21 patients, with 16 evaluable at six months, eight at nine months, and seven at 12 months as of April 16, 2025 [4] Safety Profile - Most adverse events were Grade 1 and transient, with no Grade 3 or greater treatment-related adverse events reported. Common adverse events included flu-like symptoms and urinary tract issues, which typically resolved shortly after administration [5] Efficacy Data - TARA-002 demonstrated a 100% complete response (CR) rate at any time in BCG-Unresponsive patients, with 67% CR rate at 12 months. In BCG-Naïve patients, the CR rate was 76% at any time and 43% at 12 months [6][7] Future Plans - The company is on track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 [6][8] - A conference call and webcast to discuss the data will be held on April 28, 2025 [9] About the Trial - The ADVANCED-2 trial is assessing TARA-002 in NMIBC patients with carcinoma in situ who are BCG-Unresponsive or BCG-Naïve, with a total of approximately 100 patients in the BCG-Unresponsive cohort [10] About TARA-002 - TARA-002 is an investigational cell therapy for NMIBC and has received Rare Pediatric Disease Designation from the FDA. It is developed from a master cell bank of genetically distinct group A Streptococcus pyogenes [11] About NMIBC - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases diagnosed annually [13] About Protara Therapeutics - Protara is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, including TARA-002 for NMIBC and lymphatic malformations [14]

Core Viewpoint - Protara Therapeutics is set to present updated safety and efficacy data from the Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) on April 28, 2025, with data showcased at the American Urological Association 2025 Annual Meeting on April 26, 2025 [1][2] Group 1: Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [7] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating NMIBC and lymphatic malformations (LMs) [7] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [7] Group 2: Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is a Phase 2 open-label study assessing TARA-002 in NMIBC patients who are BCG-unresponsive or BCG-naïve [3] - The trial includes approximately 100 BCG-unresponsive patients and 31 BCG-naïve patients, with the BCG-unresponsive cohort designed to be registrational [3] Group 3: Product Information - TARA-002 is derived from a master cell bank of genetically distinct group A Streptococcus pyogenes, similar to OK-432, which is marketed in Japan [4] - The therapy is hypothesized to activate immune cells and induce a pro-inflammatory response, enhancing the antitumor immune response [5] Group 4: Disease Context - NMIBC accounts for about 80% of bladder cancer diagnoses, with approximately 65,000 new cases diagnosed annually in the United States [6]

Core Viewpoint - Protara Therapeutics has appointed Dr. Leonardo Viana Nicacio as Chief Medical Officer, bringing nearly 20 years of experience in oncology and drug development to the company [1][2]. Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [5]. - The company's lead candidate, TARA-002, is an investigational cell-based therapy for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [5]. - Protara is conducting a Phase 2 trial for TARA-002 in NMIBC patients who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [5]. Leadership Appointment - Dr. Nicacio previously served as Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics, where he established global solid tumor development strategies [2]. - His experience includes significant roles at Seagen, AstraZeneca, Flatiron Health, Sanofi, and YM Biosciences, focusing on oncology and drug development [3]. - Dr. Nicacio holds a Medical Degree from Faculdade de Ciencias Medicas de Minas Gerais and is board-certified in internal medicine and medical oncology [4]. Future Prospects - Dr. Nicacio expressed optimism about Protara's pipeline, highlighting the potential to impact patients with underserved cancers and rare diseases [4]. - Important milestones are anticipated, including the presentation of interim data from the ADVANCED-2 clinical trial of TARA-002 in NMIBC patients later this month [4]. Compensation Details - As part of his employment, Dr. Nicacio received an inducement grant of options to purchase 150,000 shares at an exercise price of $4.17, along with a restricted stock unit (RSU) award for 50,000 shares [6][7].

Core Insights - Protara Therapeutics, Inc. is presenting findings from the ongoing Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) at the AUA 2025 Annual Meeting [1][2][3] 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 [10] - TARA-002 is an investigational cell therapy for NMIBC and lymphatic malformations (LMs), having received Rare Pediatric Disease Designation from the FDA [6][10] Trial Details - The ADVANCED-2 trial is assessing TARA-002 in NMIBC patients who are Bacillus Calmette-Guérin (BCG)-unresponsive or naïve, with approximately 100 patients in the BCG-unresponsive cohort and 30 in the BCG-naïve cohort [3] - The trial is designed to align with the FDA's guidance for developing treatments for BCG-unresponsive NMIBC [3] Presentation Information - Two presentations and a panel discussion on the ADVANCED-2 trial will occur at the AUA 2025 Annual Meeting from April 26 to April 29, 2025 [1] - The interim analysis abstract for the ADVANCED-2 trial is available on the AUA website, featuring updated safety and efficacy data [2] Mechanism of Action - TARA-002 is hypothesized to activate immune cells within the tumor, producing a pro-inflammatory response and releasing cytokines, while also directly killing tumor cells and inducing immunogenic cell death [8] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses, with around 65,000 new cases diagnosed annually in the United States [9]

Protara Therapeutics (TARA) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a changin ...

Data to be featured during oral presentation at the American Society for Parenteral and Enteral Nutrition 2025 Nutrition Science & Practice ConferenceDosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in 1H 2025 NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (NASDAQ:TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that da ...