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Protara Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update
Newsfilter· 2025-03-05 13:00
Core Insights - Protara Therapeutics, Inc. is focused on developing transformative therapies for cancer and rare diseases, with significant progress reported in their clinical pipeline [2][16] - The company announced positive six-month data from the Phase 2 ADVANCED-2 trial for TARA-002 in non-muscle invasive bladder cancer (NMIBC) and plans to report initial 12-month data by mid-2025 [2][5] - Protara is set to initiate the pivotal THRIVE-3 trial for intravenous Choline Chloride in the first half of 2025, targeting patients on parenteral support [4][5] Recent Progress and Highlights - Positive interim results from the ADVANCED-2 trial showed a complete response (CR) rate of 72% at six months for NMIBC patients [6] - The company has a cash position of $170 million as of December 31, 2024, which is expected to fund operations into 2027 [5][14] - The THRIVE-3 trial will assess the efficacy and safety of IV Choline Chloride over 24 weeks in patients unable to receive oral or enteral nutrition [4][15] Financial Results - For Q4 2024, Protara reported a net loss of $12.8 million, or $0.48 per share, compared to a net loss of $10.2 million, or $0.90 per share, in Q4 2023 [14][20] - Research and development expenses increased to $9.5 million in Q4 2024 from $6.4 million in the prior year, primarily due to clinical trial activities [14][20] - Total operating expenses for the full year 2024 were $49.2 million, up from $43.6 million in 2023 [20]
Protara Therapeutics to Present at the TD Cowen 45th Annual Health Care Conference
Globenewswire· 2025-02-26 13:00
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, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - Protara is conducting ongoing Phase 2 trials 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 in pediatric patients with LMs [3] Upcoming Events - Management will participate in a fireside chat at the TD Cowen 45 Annual Health Care Conference on March 5, 2025, at 9:50 am ET in Boston [1] - A live webcast of the fireside chat will be available on the company's website and will be archived for a limited time after the presentation [2] Additional Developments - 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]
Protara Therapeutics to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference
Globenewswire· 2025-02-05 13:00
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 targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [3] - Protara is conducting a 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 [3] - Additionally, Protara is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition [3] Upcoming Events - Management will participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 12:40 pm ET [1] - A live webcast of the fireside chat will be available on the company's website and archived for a limited time [2]
Protara Highlights Recent Updates and Anticipated 2025 Milestones
Globenewswire· 2025-01-13 13:00
Core Insights - Protara Therapeutics reported positive six-month data from the ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) and completed a public offering of approximately $100 million, extending its financial runway into 2027 [1][2][7] - The company anticipates key milestones in 2025, including initial data from 12-month evaluable NMIBC patients in the ADVANCED-2 trial and the commencement of the THRIVE-3 registrational trial of IV Choline Chloride [1][2][3][10] Group 1: TARA-002 in NMIBC - The ADVANCED-2 trial reported a complete response (CR) rate of 72% at six months and 70% at any time for BCG-Unresponsive patients, with a favorable safety profile [3][4] - The company plans to report data on 12-month evaluable patients in mid-2025 and results from a futility analysis of approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 [1][3] - Protara is exploring systemic priming dosing and combination therapy with TARA-002 for NMIBC patients [4] Group 2: IV Choline Chloride - The THRIVE-3 registrational trial for IV Choline Chloride is expected to begin in the first half of 2025, targeting patients dependent on parenteral support [1][10] - Previous studies indicated that 78% of PS-dependent patients were choline deficient, with 63% showing liver dysfunction [10] Group 3: Financial Guidance - Protara reported approximately $81.5 million in cash and equivalents as of September 30, 2024, along with the $100 million from the public offering, which is expected to fund operations into 2027 [7]
Protara Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-08 13:00
Core Insights - Protara Therapeutics, Inc. will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 16, 2025, at 7:30 am PT in San Francisco [1] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [3] - 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) [3] - TARA-002 is currently being evaluated in a Phase 2 trial for NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as in a Phase 2 trial for pediatric patients with LMs [3] - Additionally, Protara is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]
Protara Announces Closing of $100 Million Public Offering
GlobeNewswire News Room· 2024-12-11 21:05
Core Points - Protara Therapeutics, Inc. has closed an underwritten public offering of 13,690,000 shares of common stock at a price of $6.25 per share, along with pre-funded warrants for 2,325,372 shares at $6.249 each, raising approximately $100 million in gross proceeds [1][2][3] Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 2,402,305 shares at the public offering price [1] - The net proceeds will be used to fund the clinical development of TARA-002 and other clinical programs, as well as for working capital and general corporate purposes [1] Group 2: Underwriters - TD Cowen, Cantor, LifeSci Capital, Oppenheimer & Co., and Scotiabank served as joint book-running managers for the offering [2] Group 3: Regulatory Information - The shares and warrants were issued under an effective shelf registration statement declared effective on November 14, 2023, by the U.S. Securities and Exchange Commission [3]
Protara Therapeutics to Present New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC at the 25th Annual Meeting of the Society of Urologic Oncology
GlobeNewswire News Room· 2024-11-15 22:52
Core Insights - Protara Therapeutics, Inc. is advancing TARA002, a cell therapy for non-muscle invasive bladder cancer (NMIBC), with interim data from the Phase 2 ADVANCED-2 trial to be presented at the Society of Urologic Oncology's annual meeting in December 2024 [1][3] - The ADVANCED-2 trial includes BCG-unresponsive and BCG-naïve patients, with a focus on safety and efficacy data from approximately 20 enrolled patients [2][3] - TARA-002 is derived from a master cell bank of genetically distinct group A Streptococcus pyogenes and has shown manufacturing comparability with OK432, an approved immunopotentiator [3][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases, with TARA-002 as its lead candidate for NMIBC and lymphatic malformations [6] - The company is also developing IV Choline Chloride for patients on parenteral nutrition [6] Industry Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year, making it a significant area of focus for treatment advancements [5]
Protara Therapeutics to Present at the Guggenheim Inaugural Healthcare Innovation Conference
GlobeNewswire News Room· 2024-11-06 13:00
NEW YORK, Nov. 06, 2024 (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 management will participate in a fireside chat at the Guggenheim Inaugural Healthcare Innovation Conference on Wednesday, November 13, 2024, at 2:00 pm ET in Boston. A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: htt ...
Protara Therapeutics Announces Results from THRIVE-1, a Prospective Observational Study Evaluating the Prevalence of Choline Deficiency and Liver Injury in Patients Dependent on Parenteral Support
GlobeNewswire News Room· 2024-09-09 12:00
Core Insights - Protara Therapeutics announced the results of the THRIVE-1 study, highlighting a significant prevalence of choline deficiency and liver dysfunction in patients dependent on parenteral support [1][2][4] - The company is developing IV Choline Chloride as a potential treatment to address this unmet medical need, with plans to initiate a pivotal trial in Q1 2025 [1][3][6] Study Findings - The THRIVE-1 study involved 78 patients, revealing that 78% were choline deficient, and 63% of those with deficiency exhibited liver dysfunction, including steatosis and cholestasis [2][4] - The study underscores the critical need for intravenous choline supplementation in this patient population [2][3] Product Development - IV Choline Chloride is an investigational therapy aimed at providing choline when oral or enteral nutrition is insufficient or contraindicated [2][7] - The product has received Orphan Drug Designation from the FDA for preventing choline deficiency in patients on parenteral support [8] Market Opportunity - Approximately 40,000 patients in the U.S. on long-term parenteral support could benefit from an IV formulation of choline [8] - Currently, there are no approved IV choline products for patients dependent on parenteral support, despite recommendations from professional medical societies [5][3] Company Commitment - Protara is dedicated to bringing the first approved IV formulation of choline to the parenteral support community and is preparing for a registrational trial [3][6]
Protara Therapeutics(TARA) - 2024 Q2 - Quarterly Report
2024-08-06 12:10
Clinical Trials and Drug Development - TARA-002 is currently in a Phase 1 open-label clinical trial for non-muscle invasive bladder cancer (NMIBC), with positive preliminary data showing favorable tolerability and anti-tumor activity at the 40KE dose[83]. - In the ADVANCED-1 trial, a complete response (CR) rate of 50% was observed in BCG-Unresponsive/Experienced patients with CIS-only, while the overall CR rate across 16 evaluable patients was 38%[87]. - The ongoing ADVANCED-2 trial is assessing TARA-002 in NMIBC patients, with preliminary results from a risk-benefit analysis expected in Q4 2024, involving approximately 10 patients[89]. - TARA-002 has received Rare Pediatric Disease designation for the treatment of lymphatic malformations (LMs) and is currently being evaluated in the STARBORN-1 Phase 2 trial[95][97]. - The STARBORN-1 trial aims to enroll approximately 30 patients, with the primary endpoint being the proportion of participants demonstrating clinical success in treating macrocystic and mixed-cystic LMs[97]. - The company is exploring higher dosing at an 80KE dose and combination therapies to enhance the treatment paradigm for NMIBC[90]. - TARA-002 is being developed for multiple oncologic indications and rare diseases, with worldwide rights secured excluding Japan and Taiwan[81]. Financial Performance and Capital Needs - The company has not generated any revenue from product sales and does not expect to do so in the near term, indicating a need for additional capital to finance ongoing and future clinical trials[99]. - As of June 30, 2024, the company had an accumulated deficit of approximately $221.0 million and expects to continue incurring significant operating losses for the next few years[100]. - The company reported cash, cash equivalents, and marketable debt securities of approximately $89.6 million as of June 30, 2024, an increase from $65.6 million as of December 31, 2023[116]. - Research and development expenses for the three months ended June 30, 2024, were approximately $6.4 million, a decrease of $0.9 million compared to the same period in 2023[111]. - General and administrative expenses for the three months ended June 30, 2024, were approximately $4.3 million, a decrease of $0.6 million compared to the same period in 2023[111]. - The net loss for the three months ended June 30, 2024, was approximately $9.5 million, a decrease of $1.8 million compared to a net loss of $11.3 million for the same period in 2023[109]. - For the six months ended June 30, 2024, the company incurred a net loss of approximately $20.6 million, compared to a net loss of $20.3 million for the same period in 2023[116]. - The company completed a private placement on April 10, 2024, raising approximately $42.0 million in net proceeds by selling 9,143,380 shares of common stock[101]. - Net cash used in operating activities was $18.1 million for the six months ended June 30, 2024, a decrease of $4.2 million compared to $22.3 million for the same period in 2023[121]. - The company reported net cash provided by investing activities of $26.0 million for the six months ended June 30, 2024, compared to $32.2 million for the same period in 2023[122]. - The company believes its current financial resources are sufficient to meet estimated liquidity needs for at least twelve months from the date of the report[117]. Legal and Compliance - The company has operating lease obligations primarily for its corporate headquarters and manufacturing facilities in North America[123]. - There are no recorded liabilities for certain contracts that require indemnification against third-party claims, as amounts cannot be reasonably estimated until a specific claim is asserted[124]. - The company has contingent milestone payments related to development, regulatory approval, and commercialization agreements, which are not included in the balance sheet due to their uncertain timing[125]. - As of June 30, 2024, the company's management evaluated the effectiveness of its disclosure controls and procedures, concluding they were effective at a reasonable assurance level[128]. - There were no changes in internal control over financial reporting during the quarter ended June 30, 2024, that materially affected the company's internal control[130]. - The company is not currently involved in any legal proceedings that are likely to have a material adverse effect on its business[130].