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]

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]

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]

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]

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 ...

78% of patients dependent on parenteral support were choline deficient, with 63% of these patients demonstrating liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury IV Choline Chloride could fill a significant unmet medical need for this population Company expects to dose first patient in pivotal PK trial for IV Choline Chloride in Q1 2025 NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinicalstage company developing transformative therap ...

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].

NEW YORK, June 24, 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 the grant of inducement non-qualified stock options to purchase an aggregate of 118,400 shares of common stock to Lisa Schlesinger, Protara's newly appointed Vice President, Head of New Product Development and Market Access. About Protara Therapeutics, Inc. Justine O'Malley Protara Therapeutics Justi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock, $0.001 par value per | TARA | The Nasdaq Capital Market | | share | ...

Protara Therapeutics Announces First Quarter 2024 Financial Results and Provides Business Update NEW YORK, May 2, 2024 – Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the first quarter ended March 31, 2024 and provided a business update. "We have made significant progress thus far in 2024, and with cash resources expected to fund operations into 2026, we are well pos ...