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].
Protara Therapeutics(TARA) - 2024 Q2 - Quarterly Report