Protara Therapeutics(TARA) - 2025 Q1 - Quarterly Results

Recent Progress and Highlights Protara reported significant Q1 2025 clinical progress, including positive interim ADVANCED-2 trial results for TARA-002 in NMIBC and plans to initiate the THRIVE-3 trial for IV Choline Chloride in Q3 2025 TARA-002 in NMIBC - At the AUA 2025 Annual Meeting, updated interim results from the ADVANCED-2 trial were presented, showing promising complete response (CR) rates for TARA-002[8] ADVANCED-2 Trial Interim Results (as of April 16, 2025) | Patient Cohort | CR Rate (Any Time) | 12-Month CR Rate | | :--- | :--- | :--- | | BCG-Unresponsive | 100% (5/5) | 67% (2/3) | | BCG-Naïve | 76% (16/21) | 43% (3/7) | - TARA-002 was generally well-tolerated, with the majority of adverse events being Grade 1 and transient, and no Grade 3 or greater treatment-related adverse events reported[8] - Future milestones include announcing interim results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 and providing an update on the planned BCG-Naïve registrational trial design in H2 2025[8] IV Choline Chloride for Patients on Parenteral Support (PS) - The company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the third quarter of 2025[6] - THRIVE-3 is a seamless Phase 2b/3 trial to assess the efficacy and safety of IV Choline Chloride in adolescents and adults on long-term parenteral support[6] - IV Choline Chloride has previously been granted Fast Track designation by the FDA[6] TARA-002 in Lymphatic Malformations (LMs) - Dosing is progressing in the Phase 2 STARBORN-1 trial for pediatric patients with macrocystic and mixed cystic LMs[7] - An interim update from the STARBORN-1 trial is planned for the second half of 2025[7] Corporate Update In April 2025, Protara significantly strengthened its leadership team with the strategic appointments of a new Chief Medical Officer and a new Chief People Officer, bringing extensive experience in oncology, drug development, and life sciences organizational growth - Appointed Leonardo Viana Nicacio, M.D., as Chief Medical Officer. Dr. Nicacio has nearly 20 years of experience in oncology, drug development, and regulatory affairs, previously serving at Stemline Therapeutics[9] - Appointed Shane Williams, Ph.D., as VP, Head of Human Resources, Chief People Officer. Dr. Williams has a strong background in driving growth and building high-performing teams, most recently at Century Therapeutics[9] First Quarter 2025 Financial Results Protara reported a net loss of $11.9 million for Q1 2025, up from $11.1 million in Q1 2024 due to increased clinical trial and personnel costs, while maintaining a strong financial position with $157.5 million in cash, cash equivalents, and investments, projected to fund operations into 2027 Q1 2025 vs. Q1 2024 Financial Performance (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research & Development Expenses | $9.1 | $7.7 | | General & Administrative Expenses | $5.0 | $4.1 | | Net Loss | $11.9 | $11.1 | | Net Loss Per Share | $0.29 | $0.97 | - The increase in R&D expenses was mainly due to a $2.6 million rise in clinical trial activities for TARA-002 and IV Choline[13] - The increase in G&A expenses was primarily driven by higher personnel-related costs and professional fees[13] Financial Statements This section includes the unaudited condensed consolidated balance sheets as of March 31, 2025, compared to December 31, 2024, and the unaudited condensed consolidated statements of operations for the three-month periods ending March 31, 2025, and 2024 Unaudited Condensed Consolidated Balance Sheets Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $91,461 | $162,798 | | Total current assets | $126,532 | $172,155 | | Total assets | $168,559 | $181,454 | | Total current liabilities | $7,018 | $10,961 | | Total liabilities | $10,075 | $14,320 | | Total stockholders' equity | $158,484 | $167,134 | Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss Statement of Operations Summary (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $14,124 | $11,851 | | Income (Loss) from operations | $(14,124) | $(11,851) | | Net income (loss) | $(11,914) | $(11,095) | | Net income (loss) per share | $(0.29) | $(0.97) | | Weighted-average shares outstanding | 40,707,937 | 11,420,948 |