Protara Therapeutics(US:TARA)2025-11-10 13:10Financial Performance - As of September 30, 2025, the company had an accumulated deficit of approximately $285.1 million[132]. - The company expects to continue incurring significant and increasing expenses and operating losses for at least the next few years as it develops and seeks marketing approvals for its product candidates[132]. - Net income (loss) for Q3 2025 was $(13.3) million, compared to $(11.2) million in Q3 2024, representing an increase in loss of $2.1 million[140]. - Total operating expenses for the nine months ended September 30, 2025, were $45.5 million, an increase of $10.6 million compared to the same period in 2024[146]. - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $(39.4) million, an increase of $12.9 million compared to $(26.5) million in the same period of 2024[156]. - The company incurred a net loss of $40.1 million for the nine months ended September 30, 2025, compared to a net loss of $31.8 million for the same period in 2024[151]. - Net cash provided by financing activities was $1.8 million for the nine months ended September 30, 2025, a decrease from $42.0 million for the same period in 2024[158]. Research and Development - The ADVANCED-2 clinical trial for TARA-002 in NMIBC has enrolled 31 patients in Cohort A, with a complete response rate of 100% in BCG-Unresponsive patients at six months[117]. - The CR rate in BCG-Naïve patients was 76% at any time, with 63% at six months[118]. - The company plans to initiate the THRIVE-3 Phase 3 clinical trial for IV Choline Chloride by the end of 2025, with a primary endpoint measuring plasma choline concentration[126]. - In the THRIVE-1 study, 78% of patients dependent on parenteral support were found to be choline deficient, with 63% of those having liver dysfunction[125]. - The STARBORN-1 trial for TARA-002 in lymphatic malformations has enrolled approximately 30 patients, with interim data showing two patients achieving complete response after one injection[129]. - TARA-002 is being developed for both NMIBC and lymphatic malformations, with ongoing studies to explore its potential in combination therapies[121][127]. - IV Choline Chloride has received Orphan Drug Designation from the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition[123]. - Total research and development expenses for the nine months ended September 30, 2025, were $29.5 million, an increase of approximately $7.3 million compared to the same period in 2024[148]. Cash and Liquidity - The company has approximately $133.6 million in unrestricted cash and cash equivalents as of September 30, 2025[133]. - Unrestricted cash and cash equivalents and marketable debt securities as of September 30, 2025, were $133.6 million, down from $170.3 million as of December 31, 2024[151]. - Cash used in investing activities for the nine months ended September 30, 2025, was approximately $(112.6) million, a significant increase from $(3.3) million in the same period of 2024[157]. - Other income (expense), net for Q3 2025 was $1.5 million, an increase of approximately $0.4 million compared to Q3 2024, driven by higher returns on invested cash[145]. - Cash provided during the nine months ended September 30, 2025, included $2.5 million from the exercise of the Underwriters' Option from the December 2024 Public Offering[158]. - The cash provided during the nine months ended September 30, 2024, was primarily from $42.0 million in proceeds from the April 2024 Private Placement[158]. Obligations and Contingencies - The company has operating lease obligations for its corporate headquarters and manufacturing facilities located in North America[159]. - Certain contracts require milestone payments upon achieving specific development, regulatory, or commercial milestones, but these are not recorded as liabilities until claims are asserted[162]. - Future payments to third parties are contingent on the achievement of certain milestones and are not included on the balance sheet[163]. - The company currently has no off-balance sheet arrangements as defined by SEC regulations[164].