Core Insights - Protara Therapeutics, Inc. is hosting a conference call on November 19, 2025, to discuss new data from the interim analysis of the Phase 2 STARBORN-1 trial for TARA-002, a cell-based therapy for pediatric patients with lymphatic malformations [1][2] Group 1: 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 in development for non-muscle invasive bladder cancer and lymphatic malformations [5] - TARA-002 has received Rare Pediatric Disease designation from the U.S. FDA for the treatment of lymphatic malformations [3] Group 2: Product Details - TARA-002 is a genetically distinct strain of streptococcus pyogenes that retains immune-stimulating properties while being inactivated [3] - The therapy was developed from the same master cell banks as OK-432, which has been the standard of care in Japan for 30 years [3] - A large Phase 2 trial of OK-432 demonstrated significant clinical success in over 500 patients with lymphatic malformations [3] Group 3: Lymphatic Malformations - Lymphatic malformations are rare congenital conditions affecting lymphatic vessels, often diagnosed in early childhood [4] - More than 50% of lymphatic malformations are detected at birth, with 90% diagnosed before the age of three [4] - Common complications include airway obstruction, intralesional bleeding, and recurrent infections, leading to significant morbidity [4]

Core Insights - Protara Therapeutics, Inc. announced interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for treating non-muscle invasive bladder cancer (NMIBC) [1][2] - The trial data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology from December 2 to December 5, 2025 [1] - TARA-002 is an investigational cell therapy that has received Rare Pediatric Disease Designation from the FDA [3][6] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases [6] - The company's lead candidate, TARA-002, is being evaluated in ongoing Phase 2 trials for NMIBC and lymphatic malformations [6] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [6] Trial Details - The ADVANCED-2 trial includes BCG-Naïve patients with NMIBC, specifically those with carcinoma in situ or CIS [2] - The trial involves an induction course of six weekly intravesical instillations of TARA-002, followed by maintenance treatments [2] - The upcoming poster presentation will include updated safety and efficacy data from 31 enrolled patients [1][3] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year [5] - Bladder cancer is the sixth most common cancer in the United States [5] Mechanism of Action - TARA-002 is hypothesized to activate immune cells in the tumor, leading to a pro-inflammatory response and the release of cytokines [4] - The therapy aims to directly kill tumor cells and enhance the antitumor immune response through immunogenic cell death [4]

Core Insights - Protara Therapeutics reported significant advancements in its clinical programs, particularly in the development of TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][5][10] - The company is on track to report interim results from its ADVANCED-2 trial in NMIBC patients in Q1 2026 and expects to provide updates on its STARBORN-1 trial for pediatric LMs in Q4 2025 [6][7] Clinical Development Updates - TARA-002 is being evaluated in the ADVANCED-2 trial for NMIBC, with interim results expected from approximately 25 BCG-Unresponsive patients in early 2026 [6][7] - The STARBORN-1 trial for TARA-002 in pediatric patients with LMs is progressing, with an interim update anticipated in Q4 2025 [5][6] - The THRIVE-3 trial for IV Choline Chloride is set to dose its first patient by the end of 2025, focusing on patients dependent on parenteral support [6][7] Financial Performance - As of September 30, 2025, Protara had approximately $134 million in cash and investments, expected to fund operations into mid-2027 [6][15] - Research and development expenses increased to $9.6 million in Q3 2025 from $8.1 million in the same period of 2024, primarily due to startup costs for the THRIVE-3 trial [15][23] - The company reported a net loss of $13.3 million, or $0.31 per share, for Q3 2025, compared to a net loss of $11.2 million, or $0.50 per share, in Q3 2024 [15][23] Corporate Recognition - Protara was recognized as one of BioSpace's Best Places to Work in November 2025, highlighting its strong culture and commitment to innovation [8]

Core Insights - Protara Therapeutics, Inc. has been recognized as one of the Best Places to Work by BioSpace for 2026, highlighting its status as a desirable employer in the biotech sector [1][2] - The company is particularly noted for its commitment to fostering a vibrant workplace culture that attracts top talent and inspires employees [2][3] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [4] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [4] - Protara is currently 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 [4] - Additionally, the company is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition [4] Workplace Environment - Protara is located in the Flatiron District of New York City and emphasizes a modern, collaborative working environment that values integrity, tenacity, and teamwork [3] - The company offers competitive benefits and prioritizes professional development, inclusivity, and work-life balance [3] - The Best Places to Work nominations were based on votes from over 7,500 life sciences professionals, who evaluated companies on various attributes including compensation, innovation, and culture [3]

Core Insights - Protara Therapeutics is a clinical-stage biotech company focused on developing treatments for cancer and rare diseases, with its lead program TARA-002 targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][8] - TARA-002 utilizes a novel approach derived from a genetically distinct cell bank, functioning through dual mechanisms of directly killing tumor cells and stimulating an immune response [1][8] - The company is also advancing IV Choline Chloride for patients requiring parenteral nutrition, addressing a significant unmet need [10] TARA-002 Development - TARA-002 is currently being evaluated in a mid-stage study called ADVANCED-2 for NMIBC, showing promising early results with a 67% complete remission rate in BCG-unresponsive patients at six months [8][12] - In the Phase 2 STARBORN-1 trial for lymphatic malformations, two out of three pediatric patients achieved complete response after one injection, indicating a favorable safety profile [9][12] - Protara plans to deliver interim results for both trials in 1Q26 and 4Q25, respectively [8][9] Market Potential and Analyst Sentiment - Analysts project TARA-002 represents a potential market opportunity exceeding $500 million, with a strong buy consensus rating and a price target suggesting an 840% upside [12][13] - The average price target from analysts for TARA shares is $24.20, indicating a potential upside of approximately 659% [13] Financial Performance of Alpha Teknova - Alpha Teknova reported $10.3 million in revenue for 2Q25, a 7.3% year-over-year increase, with a reaffirmed full-year revenue guidance of $39-42 million [17] - The company is positioned to benefit from growth in the bioprocessing market, with expectations of over 20% revenue growth and 30%+ adjusted EBITDA margins in the long term [19][20] Analyst Ratings for Alpha Teknova - Alpha Teknova holds a strong buy consensus rating, with a price target of $12 indicating a potential one-year upside of approximately 159% [20]

Summary of Protara Therapeutics FY Conference Call Company Overview - **Company**: Protara Therapeutics (NasdaqGM:TARA) - **Date of Conference**: September 09, 2025 Key Industry and Company Insights Lymphatic Malformations - The largest data set on lymphatic malformations was generated by the University of Iowa, involving over 550 patients across 27 centers [1] - Protara is preparing a registration package for FDA submission, leveraging this data set and experience from Japan to seek accelerated approval [1] - TARA-002 is positioned as a treatment for BCG-unresponsive patients, with a focus on its unique mechanism of action compared to BCG [2][3] Mechanism of Action - TARA-002 acts as a TLR2/NOD2 activator, differing significantly from BCG, which is a TLR4 activator [2] - TARA-002 has demonstrated three-year stability at refrigerated temperatures and can be administered easily without special handling [2] - The drug upregulates key cytokines such as TNF-alpha, interferon-gamma, and IL-12, which are important for immune activation, while down-regulating IL-8, associated with recurrence [3][4] Clinical Trials and Data - Protara is currently enrolling patients in an Advanced II study for NMIBC (non-muscle invasive bladder cancer) and plans to publish interim data in February [4] - The company has reported a complete response rate of over 70% at six months and over 40% at twelve months in BCG-naive patients [6] - A significant portion of BCG-eligible patients (approximately 35%) do not receive BCG treatment, presenting an opportunity for TARA-002 [5] Safety and Efficacy - TARA-002 has shown no treatment-related grade 3 adverse events, with common side effects being mild and related to administration [7] - The administration process is straightforward, with efficacy comparable to other products in development [8] IV Choline Chloride Program - Protara is also developing IV Choline Chloride as a therapy for patients on parenteral support, addressing metabolic deficiencies [9][10] - The pivotal study aims to demonstrate elevated choline levels in serum as a primary endpoint, with interim data expected in mid-2026 [10][11] Market Potential and Future Directions - The incidence of lymphatic malformations is estimated at 1 in 2,000 to 1 in 4,000 live births, with a significant portion being macrocystic [15][16] - Protara aims to expand TARA-002's application to other maxillofacial cysts, potentially addressing a larger patient population [17] - The company holds $146 million in cash, sufficient to fund operations through 2027 and multiple catalysts in 2026 [18] Additional Important Points - Protara is actively engaging with the FDA regarding study designs for BCG alternative settings [5] - The company is focused on differentiating its product profile to drive adoption in a competitive market [7] - The ongoing studies and data collection are critical for establishing TARA-002's efficacy and safety in various patient populations [12][14]

Core Insights - Protara Therapeutics, Inc. reported financial results for Q2 2025, highlighting ongoing clinical trials and business updates [1][10] Clinical Development - The company is advancing its pipeline, particularly the ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC), with interim results expected in Q1 2026 [2][7] - Protara is on track to initiate dosing in the THRIVE-3 trial of IV Choline Chloride for patients dependent on parenteral support by the end of Q3 2025, with EU enrollment anticipated soon [4][7] - The STARBORN-1 trial of TARA-002 in pediatric patients with lymphatic malformations is ongoing, with an interim update expected in Q4 2025 [5][7] Financial Performance - As of June 30, 2025, Protara had approximately $146 million in cash and equivalents, sufficient to support operations into mid-2027 [7][16] - Research and development expenses increased to $10.8 million in Q2 2025 from $6.4 million in the same period of 2024, primarily due to clinical trial activities [16][22] - The company reported a net loss of $15.0 million, or $0.35 per share, compared to a net loss of $9.5 million, or $0.45 per share, in Q2 2024 [16][23] Corporate Updates - William "Bill" Conkling was appointed as Chief Commercial Officer in June 2025, bringing over 20 years of experience in developing and commercializing novel therapeutics [6][9] - Protara was added to the Russell 3000® Index effective June 30, 2025, enhancing its visibility in the market [9]

Group 1 - Protara Therapeutics has been added to the Russell 3000 Index, effective June 30, 2025, reflecting the company's progress in executing its pipeline [1][2] - The inclusion in the Russell 3000 Index enhances Protara's visibility among the financial community, which is crucial for attracting investment and generating shareholder value [2] - The Russell US Indexes reconstitution captures the 4,000 largest U.S. stocks ranked by market capitalization, with approximately $10.6 trillion in assets benchmarked against these indices as of June 2024 [2] Group 2 - Protara is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with its lead candidate being TARA-002 [3] - TARA-002 is currently undergoing Phase 2 trials for non-muscle invasive bladder cancer and lymphatic malformations, targeting patients unresponsive to Bacillus Calmette-Guérin treatment [3] - The company is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]

Core Insights - Protara Therapeutics has appointed William "Bill" Conkling as Chief Commercial Officer, bringing over 20 years of experience in developing and commercializing therapies for cancer and rare diseases [1][2][3] - The company is positioned for growth with a potentially best-in-class bladder cancer therapy and two de-risked rare disease programs, aiming to significantly impact patient outcomes [2][5] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on transformative therapies for cancer and rare diseases, with its lead candidate TARA-002 in development 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 who are unresponsive or naïve to Bacillus Calmette-Guérin treatment, as well as in pediatric patients with lymphatic malformations [5] Leadership Background - Bill Conkling previously served as President and CEO of Rafael Holdings, where he built the commercial organization and developed go-to-market strategies [2][3] - He has extensive experience in the oncology field, having led the U.S. commercial organization for the launch of Trodelvy at Immunomedics and held key roles at Novartis Pharmaceuticals, including the commercialization of Kymriah [3][4] Stock Options and Awards - As part of his employment, Mr. Conkling received an inducement grant of options to purchase 200,000 shares at an exercise price of $3.30, along with a restricted stock unit award for 50,000 shares [6] - The options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly over the following 36 months [6]

Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [2] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2] - 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 (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [2] Upcoming Events - Protara management will participate in the H.C. Wainwright & Co. 3 Annual BioConnect Investor Conference with a fireside chat scheduled for May 20, 2025, at 12:30 pm ET in New York [3] - The company will also take part in the TD Cowen 6 Annual Oncology Innovation Summit, which will be held virtually on May 27, 2025, at 1:30 pm ET [3] 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 [2] - Live webcasts of the investor conferences will be available on the company's website and archived for a limited time [1]